Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT02404935
Status:
COMPLETED
Last Update Posted:
2022-03-24
First Post:
2015-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
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': 'D000068818', 'term': 'Cetuximab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival at 6 months', 'timeFrame': '6 months after start of maintenance therapy', 'description': 'Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic colorectal cancer', 'cetuximab', 'maintenance'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '37721754', 'type': 'DERIVED', 'citation': 'Boige V, Blons H, Francois E, Ben Abdelghani M, Phelip JM, Le Brun-Ly V, Mineur L, Galais MP, Villing AL, Hautefeuille V, Miglianico L, De La Fouchardiere C, Genet D, Levasseur N, Levache CB, Penel N, Mitry E, Jacquot S, Aparicio T, Brument E, Gourgou S, Castan F, Bouche O. Maintenance Therapy With Cetuximab After FOLFIRI Plus Cetuximab for RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333533. doi: 10.1001/jamanetworkopen.2023.33533.'}]}, 'descriptionModule': {'briefSummary': 'National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed colorectal cancer\n2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis\n3. Non resectable metastatic disease in a curative intent\n4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion\n5. At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated\n6. Life expectancy above 3 months\n7. Performance Status ≤2 (WHO)\n8. Patient ≥18 years-old\n9. Acceptable blood test\n10. Patient having signed a written informed consent form\n\nExclusion Criteria:\n\n1. Known and/or symptomatic brain metastases\n2. Known allergy to one of treatment components\n3. Neurological or psychiatric condition which could interfere with good treatment compliance\n4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation\n5. Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan\n6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization\n7. Concomitant severe infection\n8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)\n9. Patient already included in another clinical trial with an investigational molecule\n10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)\n11. Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment\n12. Those deprived of their freedom or under guardianship\n13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons"}, 'identificationModule': {'nctId': 'NCT02404935', 'acronym': 'TIME', 'briefTitle': 'Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)', 'organization': {'class': 'OTHER', 'fullName': 'UNICANCER'}, 'officialTitle': 'Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Prodige 28 - UCGI 27 (TIME)'}, 'secondaryIdInfos': [{'id': '2012-005139-99', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A cetuximab', 'description': 'cetuximab 500 mg/m2 (every 2 weeks) until progression', 'interventionNames': ['Drug: Cetuximab', 'Drug: FOLFIRI and cetuximab']}, {'type': 'OTHER', 'label': 'Arm B observation', 'description': 'observation until progression', 'interventionNames': ['Drug: FOLFIRI and cetuximab']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'armGroupLabels': ['Arm A cetuximab']}, {'name': 'FOLFIRI and cetuximab', 'type': 'DRUG', 'armGroupLabels': ['Arm A cetuximab', 'Arm B observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU- Hôpital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '89011', 'city': 'Auxerre', 'country': 'France', 'facility': "Centre Hospitalier d'Auxerre", 'geoPoint': {'lat': 47.7996, 'lon': 3.57033}}, {'zip': '84918', 'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Cote Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'Centre Hospitalier de Beauvais', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '34500', 'city': 'Béziers', 'country': 'France', 'facility': 'Centre Hospitalier de Béziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '41000', 'city': 'Blois', 'country': 'France', 'facility': 'Centre Hospitalier de Blois', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinqiue Tivoli', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Hôpital Côte de nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '46000', 'city': 'Cahors', 'country': 'France', 'facility': 'Centre Hospitalier Jean Rougier', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'city': 'Cahors', 'country': 'France', 'facility': 'Centre Hospitalier Jean Rougier', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Hospitalier Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Hôpital du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '83007', 'city': 'Draguignan', 'country': 'France', 'facility': 'Centre Hospitalier de la Dracénie', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '91035', 'city': 'Évry', 'country': 'France', 'facility': 'Clinique du Mousseau', 'geoPoint': {'lat': 48.6328, 'lon': 2.44049}}, {'zip': '83007', 'city': 'Fréjus', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal', 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre hospitalier Départemental de Vendée - 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