Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-18 @ 5:47 PM
Study NCT ID:
NCT02175095
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
[18F]FLT-PET as a Predictive Imaging Biomaker of Treatment Responses to Regorafenib
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yshong@amc.seoul.kr', 'phone': '+82-2-3010-3227', 'title': 'Yong Sang Hong, M.D., Ph.D.', 'organization': 'Asan Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Regorafenib and FLT-PET', 'description': "After checking the eligibility for the study entry, patients will be scheduled to perform \\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \\[18F\\]FDG-PET will be performed before treatment and at 8 weeks (just once at the point of first response evaluation).\n\nRegorafenib: After checking the eligibility for the study entry, patients will be scheduled to perform \\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy).", 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 3, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hand foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated AST/ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Early Response by 18F-Fluorodeoxyglucose(18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Response Evaluation Criteria In Solid Tumors Criteria (RECIST)', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.\n\nComplete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD'}, {'id': 'OG001', 'title': 'PET Response Criteria in Solid Tumours (PERCIST)', 'description': 'Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.\n\nThe peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point.\n\nThe percentage of change in SULpeak in the measurable target lesion was computed as follows:\n\n100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described.\n\nComplete metabolic response (CMR)= complete resolution of 18F-FDG uptake within the measurable target lesion/disappearance of all other lesions to background blood pool levels/no new suspicious 18F-FDG avid lesions; Partial metabolic response (PMR)=reduction of a minimum of 30% in target measurable tumor 18F-FDG SUL peak, with absolute drop in SUL of at least 0.8 SUL units/no increase \\>30% of SUL or size in all other lesions; Stable metabolic disease (SMD)=no CMR, PMR, or progressive metabolic disease (PMD); Progressive metabolic disease (PMD)=\\>30% increase in 18F-FDG SUL peak, with \\>0.8 SUL units increase in tumor SUL from the baseline scan in pattern typical of tumor and not of infection/treatment effect or new 18F-FDG avid lesions typical of cancer and not related to treatment effect and/or infection'}], 'classes': [{'title': 'Partial response; Partial metabolic response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Stable disease; Stable metabolic disease', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease; Progressive metabolic disease', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.', 'description': 'Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0. The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point. For a tumour to be measurable at baseline, the SULpeak in the target lesion was greater than or equal to 1.5 times the mean SUL in the 3-cm-diameter spherical volume of interest plus two times its standard deviation of the liver. The percentage of change in SULpeak in the measurable target lesion was computed as follows: 100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Both 18F-FLT and 18F-FDG PET/CT scans were performed in 64 patients; among the remaining four patients, one withdrew consent and three discontinued Regorafenib treatment during the first cycle because of toxicities. With the exception of three patients who had no follow-up CT (n = 2) or no uptake of 18F-FLT (n = 1), 61 were evaluable for the treatment response on both CT and PET/CT in final.'}, {'type': 'PRIMARY', 'title': "Assessment of Early Response by Using 3'-Deoxy-3'-18F-fluorothymidine (18F-FLT) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders and Non-responders on CT and 18F-FLT PET/CT', 'description': 'By CT scan Responders met the criteria PR according to RECIST criteria. Other than, Non-responders.\n\nBy 18F-FLT PET/CT The non-responders on 18F-FLT PET/CT were defined as those with decreased SUVmax \\<10.6% or new lesions on a follow-up scan.\n\nThe responders on 18F-FLT PET/CT were defined as those with decreased SUVmax ≥10.6%.'}], 'classes': [{'title': 'Responders on 18F-FLT PET/CT and Responders on RECIST', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Responders on 18F-FLT PET/CT and Non-Responders on RECIST', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Non-Responders on 18F-FLT PET/CT and Responders on RECIST', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-Responders on 18F-FLT PET/CT and Non-Responders on RECIST', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.', 'description': 'PET response of 18F-FLT was assessed using the SUVmax. The percentage of change of SUVmax in the target lesion was calculated as follows: 100 ×(SUVmax day 21-SUVmax baseline)/SUVmax baseline. The non responders on 18F-FLT PET/CT were defined as those with decreased SUVmax \\<10.6% or new lesions on a follow-up scan.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Survival Outcomes According to 18F-FLT and 18F-FDG PET/CT Response on Day 21 of Regorafenib and RECIST on CT at 8 Weeks of Regorafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '56', 'groupId': 'OG009'}, {'value': '46', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Partial Metabolic Response Group (PMR Group)', 'description': 'PMR, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.'}, {'id': 'OG001', 'title': 'Non-Partial Metabolic Response Group(Non-PMR Group)', 'description': 'SMD+PMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.'}, {'id': 'OG002', 'title': 'Non-progressive Metabolic Disease Group (Non-PMD Group)', 'description': 'PMR+SMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.'}, {'id': 'OG003', 'title': 'Progressive Metabolic Disease Group (PMD Group)', 'description': 'PMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.'}, {'id': 'OG004', 'title': 'Responders on 18F-FLT PET/CT', 'description': 'patients showing a decrease of SUVmax ≥10.6%'}, {'id': 'OG005', 'title': 'Non-Responders on 18F-FLT PET/CT', 'description': 'patients showing a decrease of SUVmax \\<10.6% or new lesion.'}, {'id': 'OG006', 'title': 'Concordant Pairs of Responders on Day 21 18F-FLT PET/CT and 8 Weeks CT', 'description': 'All the responders on 18F-FLT PET/CT met the criteria for responders on 8weeks CT'}, {'id': 'OG007', 'title': 'Concordant Pairs of Non-responders on Day 21 18F-FLT PET/CT and 8 Weeks CT', 'description': 'All the non-responders on 18F-FLT PET/CT met the criteria for non-responders on 8weeks CT'}, {'id': 'OG008', 'title': 'Partial Response Group (PR Group)', 'description': 'PR, according to RECIST on CT at 8 weeks of Regorafenib.'}, {'id': 'OG009', 'title': 'Non-Partial Response Group (Non-PR Group)', 'description': 'SD+PD, according to RECIST on CT at 8 weeks of Regorafenib.'}, {'id': 'OG010', 'title': 'Non-Progressive Disease Group (Non-PD Group)', 'description': 'PR+SD, according to RECIST on CT at 8 weeks of Regorafenib'}, {'id': 'OG011', 'title': 'Progressive Disease Group (PD Group)', 'description': 'PD, according to RECIST on CT at 8 weeks of Regorafenib'}], 'classes': [{'title': 'Progression-free survival(PFS)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '6.27'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3.26', 'upperLimit': '3.76'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '3.79'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '3.18', 'upperLimit': '4.02'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '1.93', 'upperLimit': '5.87'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '2.72', 'upperLimit': '4.16'}, {'value': '9.0', 'groupId': 'OG006', 'lowerLimit': '2.44', 'upperLimit': '15.53'}, {'value': '3.4', 'groupId': 'OG007', 'lowerLimit': '2.72', 'upperLimit': '4.16'}, {'value': '8.9', 'groupId': 'OG008', 'lowerLimit': '2.43', 'upperLimit': '15.53'}, {'value': '3.5', 'groupId': 'OG009', 'lowerLimit': '3.45', 'upperLimit': '3.63'}, {'value': '5.3', 'groupId': 'OG010', 'lowerLimit': '3.36', 'upperLimit': '7.33'}, {'value': '1.6', 'groupId': 'OG011', 'lowerLimit': '1.33', 'upperLimit': '1.88'}]}]}, {'title': 'Overall survival (OS)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '7.54', 'upperLimit': '16.13'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '5.25', 'upperLimit': '10.62'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '2.22', 'upperLimit': '6.18'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '8.07', 'upperLimit': '12.83'}, {'value': '11.6', 'groupId': 'OG004', 'lowerLimit': '7.33', 'upperLimit': '13.85'}, {'value': '7.0', 'groupId': 'OG005', 'lowerLimit': '4.45', 'upperLimit': '9.45'}, {'value': '10.6', 'groupId': 'OG006', 'lowerLimit': '7.33', 'upperLimit': '13.85'}, {'value': '7.0', 'groupId': 'OG007', 'lowerLimit': '4.45', 'upperLimit': '9.45'}, {'value': '22.5', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '45.64'}, {'value': '9.2', 'groupId': 'OG009', 'lowerLimit': '7.47', 'upperLimit': '11.01'}, {'value': '10.7', 'groupId': 'OG010', 'lowerLimit': '8.00', 'upperLimit': '13.37'}, {'value': '4.6', 'groupId': 'OG011', 'lowerLimit': '1.83', 'upperLimit': '7.48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Regardless of the reason for discontinuation, all subjects will be followed for survival until death is documented, except for those who specifically withdraw consent to follow-up.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regorafenib and FLT-PET', 'description': "After checking the eligibility for the study entry, patients will be scheduled to perform \\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \\[18F\\]FDG-PET will be performed before treatment and at 8 weeks (just once at the point of first response evaluation).\n\nRegorafenib: After checking the eligibility for the study entry, patients will be scheduled to perform \\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Regorafenib and FLT-PET', 'description': 'Baseline characteristics of patients with metastatic colorectal cancer receiving Regorafenib'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG Performance Status 0-1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'GRADE 0=Fully active, able to carry on all pre-disease performance without restriction GRADE 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work', 'unitOfMeasure': 'Participants'}, {'title': 'Primary tumour', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Right colon', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Left colon', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Rectum', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Well differentiated', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Moderately differentiated', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Poorly differentiated', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Mucinous differentiated', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Initially metastatic', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Recurrence with metastasis', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Site of metastasis', 'classes': [{'title': 'Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Lymph node, abdomen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Peritoenum/omentum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Ovary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Radiologic assessments using RECIST 1.1 which is for accurate comparisons between anatomical imaging and \\[ 18F\\]FLT-PET scans. Additional CT or MRI scans are highly recommended at the same day when the baseline \\[18F\\]FLT-PET is planned', 'unitOfMeasure': 'Participants'}, {'title': 'RAS status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Wild', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Mutant', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BRAF status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Wild', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Mutant', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous targeted agents', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Any', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous chemotherapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': '2 lines of chemotherapy', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '3 lines of chemotherapy', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '≥4 lines of chemotherapy', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous targeted agents', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Anti-VEGF but not anti-EGFR', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Anti-EGFR but not anti-VEGF', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Anti-VEGF and anti-EGFR', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This status was for the patient who got previous targeted agents.'}], 'populationDescription': 'Between July 2014 and June 2016, we enrolled 68 patients with mCRC who showed progression after all standard therapies, and initiated Regorafenib administration (160 mg/day) at Asan Medical Center in Seoul, Republic of Korea.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a imaging biomarker study to evaluate feasibility of \\[18F\\]FLT-PET as a potential candidate for predictive imaging biomarker of regorafenib treatment in mCRC patients who progressed after prior standard therapies.\n\nThe mCRC patients who failed to all 3 active cytotoxic chemotherapy (fluoropyrimidines, oxaliplatin and irinotecan) with or without targeted agents will be accrued. Patients will be scheduled to perform \\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib.\n\nRegorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle.\n\nStandard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \\[ 18F\\]FDG-PET will be performed before treatment and at 21 days after treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2014-06-23', 'resultsFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-10', 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Early Response by 18F-Fluorodeoxyglucose(18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks', 'timeFrame': 'Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.', 'description': 'Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0. The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point. For a tumour to be measurable at baseline, the SULpeak in the target lesion was greater than or equal to 1.5 times the mean SUL in the 3-cm-diameter spherical volume of interest plus two times its standard deviation of the liver. The percentage of change in SULpeak in the measurable target lesion was computed as follows: 100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.'}, {'measure': "Assessment of Early Response by Using 3'-Deoxy-3'-18F-fluorothymidine (18F-FLT) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks", 'timeFrame': 'Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.', 'description': 'PET response of 18F-FLT was assessed using the SUVmax. The percentage of change of SUVmax in the target lesion was calculated as follows: 100 ×(SUVmax day 21-SUVmax baseline)/SUVmax baseline. The non responders on 18F-FLT PET/CT were defined as those with decreased SUVmax \\<10.6% or new lesions on a follow-up scan.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.'}, {'measure': 'Survival Outcomes According to 18F-FLT and 18F-FDG PET/CT Response on Day 21 of Regorafenib and RECIST on CT at 8 Weeks of Regorafenib', 'timeFrame': 'Regardless of the reason for discontinuation, all subjects will be followed for survival until death is documented, except for those who specifically withdraw consent to follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['regorafenib', 'fluorothymidine', 'positron emission tomography', 'metastatic colorectal cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '22949147', 'type': 'BACKGROUND', 'citation': 'Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. 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Targeted-therapy and imaging response: a new paradigm for clinical evaluation? Rev Recent Clin Trials. 2011 Sep;6(3):259-65. doi: 10.2174/157488711796575540.'}, {'pmid': '19136215', 'type': 'BACKGROUND', 'citation': 'Desar IM, van Herpen CM, van Laarhoven HW, Barentsz JO, Oyen WJ, van der Graaf WT. Beyond RECIST: molecular and functional imaging techniques for evaluation of response to targeted therapy. Cancer Treat Rev. 2009 Jun;35(4):309-21. doi: 10.1016/j.ctrv.2008.12.001. Epub 2009 Jan 10.'}, {'pmid': '17947718', 'type': 'BACKGROUND', 'citation': 'Chen W, Delaloye S, Silverman DH, Geist C, Czernin J, Sayre J, Satyamurthy N, Pope W, Lai A, Phelps ME, Cloughesy T. Predicting treatment response of malignant gliomas to bevacizumab and irinotecan by imaging proliferation with [18F] fluorothymidine positron emission tomography: a pilot study. 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Epub 2011 Nov 7."}, {'pmid': '18997037', 'type': 'BACKGROUND', 'citation': "Kim SJ, Lee JS, Im KC, Kim SY, Park SA, Lee SJ, Oh SJ, Lee DS, Moon DH. Kinetic modeling of 3'-deoxy-3'-18F-fluorothymidine for quantitative cell proliferation imaging in subcutaneous tumor models in mice. J Nucl Med. 2008 Dec;49(12):2057-66. doi: 10.2967/jnumed.108.053215. Epub 2008 Nov 7."}, {'pmid': '23341544', 'type': 'BACKGROUND', 'citation': "McKinley ET, Smith RA, Zhao P, Fu A, Saleh SA, Uddin MI, Washington MK, Coffey RJ, Manning HC. 3'-Deoxy-3'-18F-fluorothymidine PET predicts response to (V600E)BRAF-targeted therapy in preclinical models of colorectal cancer. J Nucl Med. 2013 Mar;54(3):424-30. doi: 10.2967/jnumed.112.108456. Epub 2013 Jan 22."}, {'pmid': '23653240', 'type': 'BACKGROUND', 'citation': 'Nakajo M, Nakajo M, Kajiya Y, Jinguji M, Nishimata N, Shimaoka S, Nihara T, Aridome K, Tanaka S, Fukukura Y, Tani A, Koriyama C. Diagnostic performance of (1)(8)F-fluorothymidine PET/CT for primary colorectal cancer and its lymph node metastasis: comparison with (1)(8)F-fluorodeoxyglucose PET/CT. Eur J Nucl Med Mol Imaging. 2013 Aug;40(8):1223-32. doi: 10.1007/s00259-013-2424-9. Epub 2013 May 8.'}, {'pmid': '19010859', 'type': 'BACKGROUND', 'citation': 'Sohn HJ, Yang YJ, Ryu JS, Oh SJ, Im KC, Moon DH, Lee DH, Suh C, Lee JS, Kim SW. [18F]Fluorothymidine positron emission tomography before and 7 days after gefitinib treatment predicts response in patients with advanced adenocarcinoma of the lung. Clin Cancer Res. 2008 Nov 15;14(22):7423-9. doi: 10.1158/1078-0432.CCR-08-0312.'}, {'pmid': '23804324', 'type': 'BACKGROUND', 'citation': "Hong YS, Kim HO, Kim KP, Lee JL, Kim HJ, Lee SJ, Lee SJ, Oh SJ, Kim JS, Ryu JS, Moon DH, Kim TW. 3'-Deoxy-3'-18F-fluorothymidine PET for the early prediction of response to leucovorin, 5-fluorouracil, and oxaliplatin therapy in patients with metastatic colorectal cancer. J Nucl Med. 2013 Aug;54(8):1209-16. doi: 10.2967/jnumed.112.117010. Epub 2013 Jun 26."}, {'pmid': '22421192', 'type': 'BACKGROUND', 'citation': 'Mross K, Frost A, Steinbild S, Hedbom S, Buchert M, Fasol U, Unger C, Kratzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.'}, {'pmid': '22568966', 'type': 'BACKGROUND', 'citation': 'Strumberg D, Scheulen ME, Schultheis B, Richly H, Frost A, Buchert M, Christensen O, Jeffers M, Heinig R, Boix O, Mross K. Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study. Br J Cancer. 2012 May 22;106(11):1722-7. doi: 10.1038/bjc.2012.153. Epub 2012 May 8.'}, {'pmid': '21170960', 'type': 'BACKGROUND', 'citation': 'Wilhelm SM, Dumas J, Adnane L, Lynch M, Carter CA, Schutz G, Thierauch KH, Zopf D. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011 Jul 1;129(1):245-55. doi: 10.1002/ijc.25864. Epub 2011 Apr 22.'}, {'pmid': '22614970', 'type': 'BACKGROUND', 'citation': 'George S, Wang Q, Heinrich MC, Corless CL, Zhu M, Butrynski JE, Morgan JA, Wagner AJ, Choy E, Tap WD, Yap JT, Van den Abbeele AD, Manola JB, Solomon SM, Fletcher JA, von Mehren M, Demetri GD. Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial. J Clin Oncol. 2012 Jul 1;30(19):2401-7. doi: 10.1200/JCO.2011.39.9394. Epub 2012 May 21.'}]}, 'descriptionModule': {'briefSummary': 'Regorafenib is approved in the treatment for metastatic colorectal cancer patients who have been progressed after standard therapies, however, there has not been a predictive biomarker. The investigators designed this study to investigate whether \\[18F\\]FLT-PET might paly a role as a predictive imaging biomarker of treatment responses to regorafenib.', 'detailedDescription': 'Recent advances have been made in the treatments for the patients with metastatic colorectal cancer (mCRC) owing to the introductions of targeted agents, which included bevacizumab, cetuximab, panitumumab, and aflibercept. And in addition, regorafenib, a newer tyrosine kinase inhibitor (TKI), has been approved in the treatment for the mCRC patients.\n\nRegorafenib (BAY 73-4506) is an orally available multikinase inhibitor with activity against multiple targets, including tumor angiogenesis (VEGFR-1, -2, -3 and TIE-2), oncogenesis (KIT, RET, RAF-1, BRAF, and BRAFV600E), and tumor microenvironment (PDGF and FGFR). Regorafenib has shown antitumor activities in multiple solid tumors, and demonstrated significant efficacy outcomes in patients with advanced gastrointestinal stromal tumors and colorectal cancers.\n\nThe CORRECT study, which compared regorafenib vs placebo in mCRC patients who have been treated with all standard treatment, showed survival improvements with statistical significances; median OS 6.4 vs 5.0 months, HR 0.77, p=0.0052; median PFS 1.9 vs 1.7 months, HR 0.49, p\\<0.000001. Above these results, regorafenib monotherapy has been recently approved for the treatment of mCRC patients who have been refractory to all of standard therapies.\n\nHowever, there are still only a few biomarkers which have been established as predictive of treatment responses in the fields of treatments for mCRC patients; KRAS or BRAF mutations for the lack of responses to anti-EGFR agents, cetuximab or panitumumab. There still has not been any biomarker which would be predictive of treatment responses to bevacizumab, aflibercept or regorafenib. The difficulties in search for biomarkers for these agents might come from the facts as following; either bevacizumab or aflibercept does not act directly against tumor itself and should be combined with cytotoxic agents to show efficacy; regorafenib is a multikinase inhibitor which has too many potential targets.\n\nAbove these reasons, imaging modalities can be fascinating and alternative candidates for predictive biomarkers of treatment responses. Conventional anatomic imaging studies such as computed tomography (CT) scans can hardly predict the treatment responses earlier, and the RECIST using CT scans, which is widely used for measurement of treatment responses, might have several limitations for measurement of efficacy from targeted agents such as cystic necrosis without tumor shrinkage. In the CORRECT study, overall response rate by RECIST was only 1%, although the rates for disease stabilization was up to 40%, which might be a good example for the limitations of the RECIST using conventional anatomical imaging studies for the response evaluation of regorafenib.\n\nAmong imaging studies, PET scans are useful tools for the noninvasive measurement of functional changes after treatment with targeted agents, and \\[18F\\]FLT-PET is potentially useful tool for earlier prediction of treatment responses because it can detect earlier changes of cellular proliferation using \\[18F\\]FLT (fluorothymidine), a radiotraceable substitute for thymidine which is essential for DNA synthesis. Several studies have been reported that \\[18F\\]FLT-PET may allow an early assessment of the response to chemotherapy including targeted agents. There also has been a report that \\[18F\\]FLT-PET could predict treatment responses of BRAF inhibitors in the colorectal cancer xenograft model; regorafenib also has an inhibitory effect on BRAF.\n\nTherefore, the investigators have planned this study with hypothesis that \\[18F\\]FLT-PET could be useful for identifying a subgroup of mCRC patients with clinical responsiveness to regorafenib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum.\n2. Progressed after 3 active cytotoxic chemotherapy including fluoropyrimidines, oxaliplatin and irinotecan during or within 6 months of their administrations with or without targeted agents (bevacizumab or cetuximab).\n3. Extrahepatic measurable lesion(s) by RECIST 1.1.\n4. Unresectable metastatic disease.\n5. Age over 20 years old.\n6. Have a life expectancy of at least 3 months.\n7. ECOG performance status of 1 or lower.\n8. Adequate organ functions.\n9. Be willing and able to comply with the protocol for the duration of the study.\n10. Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw the study at any time, without prejudice.\n11. Women of childbearing potential and men must agree to use adequate contraception since signing of the IC form until at least 8 weeks after the last study drug administration.\n\nExclusion Criteria:\n\n1. Prior treatment of regorafenib.\n2. Liver-limited metastasis.\n3. Inability to perform \\[18F\\]FLT and \\[18F\\]FDG-PET imaging studies due to physical inability or claustrophobia.\n4. Concurrent or previous history of another primary cancer within 3 years prior to randomisation except for curatively treated cervical cancer in situ, non-melanomatous skin cancer, superficial bladder cancer (pTis and pT1) and curatively treated thyroid cancer of any stage. Concurrent, histologically confirmed, unresected thyroid cancer without distant metastasis could be allowed with the agreement of the chief principal investigator.\n5. Uncontrolled CNS metastases.\n6. Prior radiation therapy would be permitted, but non-radiated evaluable lesions should be present at study entry.\n7. Uncontrolled hypertension (\\>150/90 mmHg) despite of optimal management; anti-hypertensive drugs for BP lowering before study entry would be permitted.\n8. Congestive heart failure ≥ New York Heart Association (NYHA) class 2.\n9. Unstable angina, new-onset angina within 3 months, or history of myocardial infarction within 6 months before the study entry.\n10. Arterial or venous thromboembolism within 6 months.\n11. Serious concurrent infections or non-malignant illness.\n12. Liver cirrhosis ≥ Child-Pugh class B.\n13. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.\n14. Peripheral neuropathy of grade ≥ 2.\n15. Major surgery or significant traumatic injury within 28 days prior to study treatment.\n16. Non-healing wound, ulcer, or bone fracture.\n17. Current evidence of significant gastrointestinal bleeding or (impending) obstruction.\n18. Any hemorrhage or bleeding event of grade ≥ 3 within 4 weeks prior to the start of study medication.\n19. Proteinuria ≥ 3+ in the routine urinalysis; in this case, the total protein in the 24-hour urine collection should be measured, and the accrual is permitted if total protein \\< 3.5 g/day.\n20. Pregnant of breast-feeding subjects. Women of child-bearing potential must have pregnancy test within 7 days and a negative result must be documented before start of study treatment.\n21. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.\n22. Use of strong CYP3A4 inducers or inhibitors which are known to decrease the metabolism of regorafenib (ketoconazole, rifampin, phenytoin, carbamazepine, phenobarbital).\n23. Known hypersensitivity to the study drug or any of its excipients."}, 'identificationModule': {'nctId': 'NCT02175095', 'briefTitle': '[18F]FLT-PET as a Predictive Imaging Biomaker of Treatment Responses to Regorafenib', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': "3'-Deoxy-3'-18F-fluorothymidine Positron Emission Tomography ([18F] FLT-PET) for the Prediction of Response to Regorafenib in the Metastatic Colorectal Cancer Patients Who Progressed After All Standard Therapies", 'orgStudyIdInfo': {'id': 'FLT-PET-regorafenib'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regorafenib and FLT-PET', 'description': "After checking the eligibility for the study entry, patients will be scheduled to perform \\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \\[18F\\]FDG-PET will be performed before treatment and at 8 weeks (just once at the point of first response evaluation).", 'interventionNames': ['Drug: Regorafenib', 'Diagnostic Test: [18F]FLT-PET', 'Diagnostic Test: [18F]FDG-PET']}], 'interventions': [{'name': 'Regorafenib', 'type': 'DRUG', 'otherNames': ['Stivarga'], 'description': "Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.", 'armGroupLabels': ['Regorafenib and FLT-PET']}, {'name': '[18F]FLT-PET', 'type': 'DIAGNOSTIC_TEST', 'description': '\\[18F\\]FLT-PET scans before and on 21st day from the administration of regorafenib.', 'armGroupLabels': ['Regorafenib and FLT-PET']}, {'name': '[18F]FDG-PET', 'type': 'DIAGNOSTIC_TEST', 'description': '\\[18F\\]FDG-PET will be performed before treatment and at 21 days after treatment.', 'armGroupLabels': ['Regorafenib and FLT-PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138736', 'city': 'Seoul', 'state': 'Songpa', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong Sang Hong, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yong Sang Hong', 'investigatorAffiliation': 'Asan Medical Center'}}}}