Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-06 @ 1:21 PM
Study NCT ID:
NCT03022734
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete resection (R0) rate for rectal and liver lesions', 'timeFrame': 'after surgical resection, an average of 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Response rate (RECIST V1.1)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rectal Cancer, Metastatic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis\n* over 19 years\n* Eastern Cooperative Oncology Group 0-1\n* Proper organ function\n* more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)\n* Who should sign on the Informed consent form before participate the trial.\n\nExclusion Criteria:\n\n* Metastasis in other organ except liver\n* Chronic active hepatitis or cirrhosis\n* History of treatment for metastatic colorectal cancer\n* Subject pregnant or breast feeding\n* Uncontrolled disease\n* Have had adjuvant therapy\n* Uncontrolled peripheral nerve infection\n* Alcoholic or drug addict\n* Subject currently is enrolled in or ≤30 days from ending other clinical trial.\n* History of other type of cancer except resolved from skin cancer and cervical cancer.'}, 'identificationModule': {'nctId': 'NCT03022734', 'briefTitle': 'Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis', 'orgStudyIdInfo': {'id': '4-2016-0410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chemotherapy with radiotherapy', 'description': 'Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy', 'interventionNames': ['Drug: chemotherapy', 'Radiation: radiotherapy']}], 'interventions': [{'name': 'chemotherapy', 'type': 'DRUG', 'description': 'cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)', 'armGroupLabels': ['chemotherapy with radiotherapy']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.', 'armGroupLabels': ['chemotherapy with radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Joon Shin', 'role': 'CONTACT', 'phone': '82-2-2228-8130'}], 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang Joon Shin', 'role': 'CONTACT', 'phone': '82-2-2228-8130'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Joon Shin', 'investigatorAffiliation': 'Yonsei University'}}}}