Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT00304135
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2006-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-27', 'studyFirstSubmitDate': '2006-03-15', 'studyFirstSubmitQcDate': '2006-03-15', 'lastUpdatePostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression rate at 3 months', 'timeFrame': '2012'}, {'measure': 'Overall survival', 'timeFrame': '2012'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '2012'}, {'measure': 'Biliary complication rate', 'timeFrame': '2012'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['localized unresectable adult primary liver cancer', 'unresectable extrahepatic bile duct cancer', 'unresectable gallbladder cancer'], 'conditions': ['Extrahepatic Bile Duct Cancer', 'Gallbladder Cancer', 'Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '25241229', 'type': 'RESULT', 'citation': 'Phelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Federation Francophone de Cancerologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.\n\nPURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the 3-month progression rate in patients with unresectable, nonmetastatic cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs gemcitabine hydrochloride and oxaliplatin. (phase II)\n* Compare the overall survival of patients treated with these regimens. (phase III)\n\nSecondary\n\n* Compare toxicities of these regimens in these patients. (phase II)\n* Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens.\n* Compare the biliary complication rate in patients treated with these regimens.\n* Compare the duration of hospitalization of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease location (gallbladder vs intrahepatic biliary duct vs extrahepatic biliary duct). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo radiotherapy once daily, 5 days a week on days 1-33. Patients also receive fluorouracil IV continuously over 5 days once a week in weeks 1-5 and cisplatin IV over 15 minutes on days 1-4 and 29-32 (or days 1 or 2 and 29 or 30) in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline and then every 3 months thereafter.\n\nAfter completion of study therapy, patients are followed periodically for 2 years.\n\nPROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of cancer of the biliary tract by 1 of the following methods:\n\n * Histologic confirmation\n * Stenosis of the biliary tract by MRI, CT scan, or ECHO\n* Unresectable disease\n* Amenable to radiotherapy\n* No visceral metastases by imaging\n\n * Hepatic adenopathies that can be included in a radiation field allowed\n* No known ampulla of Vater or pancreatic cancer involving the biliary tract\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-2\n* Creatinine \\< 1.5 mg/dL\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 75,000/mm\\^3\n* Prothrombin time \\> 70%\n* Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed)\n* No unstable angina\n* No symptomatic cardiac insufficiency\n* No other comorbidity that would preclude study therapy\n* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix\n* No prior hydatid cyst or alveolar echinococciasis\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\n* No recent biliary surgery\n* No hepatic intra-arterial chemotherapy\n* No prior anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00304135', 'briefTitle': 'Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Federation Francophone de Cancerologie Digestive'}, 'officialTitle': 'Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract', 'orgStudyIdInfo': {'id': 'CDR0000470411'}, 'secondaryIdInfos': [{'id': 'FFCD-9902'}, {'id': 'SANOFI-FFCD-9902'}, {'id': 'LILLY-FFCD-9902'}, {'id': 'FFCD-FNCLCC-SFRO-9902'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radio-chimiothérapie', 'description': 'Radio-chimiothérapie', 'interventionNames': ['Drug: cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'GEMOX', 'description': 'GEMOX', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Drug: oxaliplatin']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Radio-chimiothérapie']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['GEMOX']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['GEMOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90000', 'city': 'Belfort', 'country': 'France', 'facility': 'Centre Hospitalier General', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre Hospitalier Pierre Oudot', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hopital Louis Pasteur', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '40100', 'city': 'Dax', 'country': 'France', 'facility': 'Centre Hospitalier de Dax', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'zip': '21034', 'city': 'Dijon', 'country': 'France', 'facility': 'Hopital Du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer Georges-Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': 'F-85025', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Departemental', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'facility': 'C. H. Du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '40000', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Centre Hospitalier General de Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'facility': "CHR D'Orleans - Hopital de la Source", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat - Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hopital Sebastopol, C.H.U. de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35062', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Hopital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '21140', 'city': 'Semur-en-Auxois', 'country': 'France', 'facility': 'Centre Hospitalier de Semur en Auxois', 'geoPoint': {'lat': 47.48333, 'lon': 4.33333}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopital Universitaire Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '65013', 'city': 'Tarbes', 'country': 'France', 'facility': 'Centre Hospitalier de Tarbes', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}], 'overallOfficials': [{'name': 'Bruno Chauffert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Georges Francois Leclerc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}