Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT01212718
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
2010-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-30', 'studyFirstSubmitDate': '2010-09-09', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best response to first-line chemotherapy (recist)', 'timeFrame': '1 year', 'description': 'Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).'}], 'secondaryOutcomes': [{'measure': 'overall survival, toxicity, treatment related complications, time to progression', 'timeFrame': '3-year', 'description': 'See above.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'non resectable metastasis', 'reference lesion', 'biopsy', 'thymidylate synthase quantitation'], 'conditions': ['Colorectal Cancer', 'Non Resectable Metastasis', 'Reference Lesion', 'Biopsy', 'Thymidylate Synthase Quantitation']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.', 'detailedDescription': 'Eligible were patients with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.The biopsy was taken from the reference lesion either by surgery during primary tumor resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. Intratumoral relative TS mRNA expression levels were determined using samples shipped in RNA-preserving solution or as glass slides after microdissection of tumor cells. An independent company stratified the patients according to ther relative TS mRNA expression level in TS low and TS high followed by randomization to receive either FUFA of Folfiri. Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients (\\>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy\n* a performance status WHO 0-2 (Karnofsky \\>= 60%)\n* an estimated life expectancy of at least 3 months\n* written informed consent\n\nExclusion Criteria:\n\n* patients older than 75 years not fulfilling these criteria\n* brain metastases or a secondary cane\n* a history of a systemic palliative chemotherapy\n* and an adjuvant chemotherapy (within 6 months)\n* pregnant or nursing women\n* a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical\n* laboratory and social conditions not allowing chemotherapy and follow-up'}, 'identificationModule': {'nctId': 'NCT01212718', 'acronym': 'FOGT5', 'briefTitle': 'Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Stratified and Randomized Multi-center Phase II - to Determine Potential Benefit of Treating Patients With Advanced Colorectal Cancer According to the Intratumoral TS RNA Levels', 'orgStudyIdInfo': {'id': 'FOGT5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5-FU', 'description': 'FUFA 5-flurouracil and folinic acid control', 'interventionNames': ['Drug: FUFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Folfiri', 'description': '5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm', 'interventionNames': ['Drug: systemic chemotherapy']}], 'interventions': [{'name': 'FUFA', 'type': 'DRUG', 'description': '2600/500 mg/m2 i.v. 24 h via port, 1 time weekly for six weeks, than have a break for 2 weeks (=8 weeks for 1 cycle)', 'armGroupLabels': ['5-FU']}, {'name': 'systemic chemotherapy', 'type': 'DRUG', 'description': 'CPT-11, 80 mg/m2 for 90 minutes and 5 FU/FA 2000/500 mg/m2 iv. 24h via port; 1 time weekly for six weeks, than have a break for 2 weeks', 'armGroupLabels': ['Folfiri']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'country': 'Germany', 'facility': 'Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer, Berlin Germany', 'class': 'UNKNOWN'}, {'name': 'Medac, Hamburg, Germany', 'class': 'UNKNOWN'}, {'name': 'Study Group Oncology of Gastrointestinal Tumors (FOGT)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Marko Kornmann', 'oldOrganization': 'University of Ulm'}}}}