Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT02071069
Status:
UNKNOWN
Last Update Posted:
2015-11-18
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-23', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The progression free-survival', 'timeFrame': '8 Months after the last subject participate in', 'description': 'defined as the time from enrollment to progression or death RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '18 Months after the last subject participate in', 'description': 'defined as the time from enrollment to death'}, {'measure': 'Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '3 Months after the last subject end the treatment', 'description': 'Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incurable colorectal cancer', 'maintenance therapy', 'Cetuximab'], 'conditions': ['Incurable Colorectal Cancer', 'RAS-wild-type']}, 'descriptionModule': {'briefSummary': '1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.\n2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.\n\nThis study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer\n2. Eastern Cooperative Oncology Group performance status ≤2 and\n3. life expectancy of \\>3 months were enrolled.\n4. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)\n5. None was previous exposure to Cetuximab or irinotecan .\n6. Patients had to have adequate haematological (absolute neutrophil count \\>1.5 × 109/l; platelet count \\>100 × 109/l; haemoglobin \\>9 g/dl), hepatic \\[total bilirubin \\<1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase \\<2.5 × ULN, or \\<5 × ULN in the case of hepatic metastases or \\<10 × ULN in the case of osseous metastases; alkaline phosphatase \\<2.5 × ULN, or \\<5 × ULN or \\<10 × ULN in the case of hepatic or osseous metastases, respectively\\] and renal function (creatinine clearance ≥60 ml/min)\n7. All RAS were wildtype. -\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women;\n2. Clinically significant cardiac disease;\n3. Lack of physical integrity of the upper gastrointestinal tract;\n4. History of other malignancy;\n5. Central nervous system metastases. -'}, 'identificationModule': {'nctId': 'NCT02071069', 'briefTitle': 'Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Efficacy and Tolerance of Cetuximab Combined With Irinotecan or Fluorouracil as Maintenance Therapy in Patients With RAS-wild-type Incurable Advanced Colorectal Cancer （Confirm Study）', 'orgStudyIdInfo': {'id': 'ZS-ON-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'maintenance therapy', 'description': 'Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) .\n\nAfter 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped', 'interventionNames': ['Drug: Cetuximab', 'Drug: irinotecan', 'Drug: fluorouracil']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'description': '400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks', 'armGroupLabels': ['maintenance therapy']}, {'name': 'irinotecan', 'type': 'DRUG', 'description': '180 mg/m2 IV every 2 weeks', 'armGroupLabels': ['maintenance therapy']}, {'name': 'fluorouracil', 'type': 'DRUG', 'otherNames': ['5FU'], 'description': '400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks', 'armGroupLabels': ['maintenance therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianshu Liu, Doctor', 'role': 'CONTACT', 'email': 'liu.tianshu@zs-hospital.sh.cn'}, {'name': 'Yiyi yu, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tianshu Liu, Doctor', 'role': 'CONTACT', 'email': 'liu.tianshu@zs-hospital.sh.cn', 'phone': '+861368 1973 996'}, {'name': 'yiyi yu, Master', 'role': 'CONTACT', 'email': 'yu.yiyi@zs-hospital.sh.cn', 'phone': '+86 1381 6730 912'}], 'overallOfficials': [{'name': 'Tianshu Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicine-Oncology Derpartment of Zhongshan hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianshu Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Medicine-Oncology department', 'investigatorFullName': 'Tianshu Liu', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}