Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
This study has been completed.
Sponsor:
Federation Francophone de Cancerologie Digestive
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00304135
First received: March 15, 2006
Last updated: May 27, 2016
Last verified: December 2006
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Purpose
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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: oxaliplatin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Cisplatin
Oxaliplatin
Gemcitabine
Gemcitabine hydrochloride
Genetic and Rare Diseases Information Center resources:
Liver Cancer
Biliary Tract Cancer
Gallbladder Cancer
Bile Duct Cancer
U.S. FDA Resources
Further study details as provided by Federation Francophone de Cancerologie Digestive:
Primary Outcome Measures:
- Progression rate at 3 months [ Time Frame: 2012 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: 2012 ] [ Designated as safety issue: Yes ]
- Biliary complication rate [ Time Frame: 2012 ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Radio-chimiothérapie
Radio-chimiothérapie
|
Drug: cisplatin |
|
Experimental: GEMOX
GEMOX
|
Drug: gemcitabine hydrochloride Drug: oxaliplatin |
Detailed Description:
OBJECTIVES:
Primary
- 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)
- Compare the overall survival of patients treated with these regimens. (phase III)
Secondary
- Compare toxicities of these regimens in these patients. (phase II)
- Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens.
- Compare the biliary complication rate in patients treated with these regimens.
- Compare the duration of hospitalization of patients treated with these regimens.
OUTLINE: 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.
- 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.
- 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.
Quality of life is assessed at baseline and then every 3 months thereafter.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of cancer of the biliary tract by 1 of the following methods:
- Histologic confirmation
- Stenosis of the biliary tract by MRI, CT scan, or ECHO
- Unresectable disease
- Amenable to radiotherapy
-
No visceral metastases by imaging
- Hepatic adenopathies that can be included in a radiation field allowed
- No known ampulla of Vater or pancreatic cancer involving the biliary tract
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Creatinine < 1.5 mg/dL
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 75,000/mm^3
- Prothrombin time > 70%
- Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed)
- No unstable angina
- No symptomatic cardiac insufficiency
- No other comorbidity that would preclude study therapy
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No prior hydatid cyst or alveolar echinococciasis
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No recent biliary surgery
- No hepatic intra-arterial chemotherapy
- No prior anticancer therapy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304135
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304135
Locations
| France | |
| Centre Hospitalier General | |
| Belfort, France, 90000 | |
| Centre Hospitalier Pierre Oudot | |
| Bourgoin-Jallieu, France, 38300 | |
| Hopital Louis Pasteur | |
| Colmar, France, 68024 | |
| Centre Hospitalier de Dax | |
| Dax, France, 40100 | |
| Hopital Du Bocage | |
| Dijon, France, 21034 | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Centre Hospitalier Departemental | |
| La Roche Sur Yon, France, F-85025 | |
| C. H. Du Mans | |
| Le Mans, France, 72037 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Centre Hospitalier General de Mont de Marsan | |
| Mont-de-Marsan, France, 40000 | |
| CHR D'Orleans - Hopital de la Source | |
| Orleans, France, 45100 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Hopital Sebastopol, C.H.U. de Reims | |
| Reims, France, 51092 | |
| Centre Eugene Marquis | |
| Rennes, France, 35062 | |
| Hopital Charles Nicolle | |
| Rouen, France, 76031 | |
| Centre Hospitalier de Semur en Auxois | |
| Semur en Auxois, France, 21140 | |
| Hopital Universitaire Hautepierre | |
| Strasbourg, France, 67098 | |
| Centre Hospitalier de Tarbes | |
| Tarbes, France, 65013 | |
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
| Principal Investigator: | Bruno Chauffert | Centre Georges Francois Leclerc |
More Information
Publications:
| Responsible Party: | Federation Francophone de Cancerologie Digestive |
| ClinicalTrials.gov Identifier: | NCT00304135 History of Changes |
| Other Study ID Numbers: | CDR0000470411 FFCD-9902 SANOFI-FFCD-9902 LILLY-FFCD-9902 FFCD-FNCLCC-SFRO-9902 |
| Study First Received: | March 15, 2006 |
| Last Updated: | May 27, 2016 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Keywords provided by Federation Francophone de Cancerologie Digestive:
|
localized unresectable adult primary liver cancer unresectable extrahepatic bile duct cancer unresectable gallbladder cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases Bile Duct Diseases Gemcitabine |
Oxaliplatin Cisplatin Fluorouracil Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016