Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
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.
Extrahepatic Bile Duct Cancer
Drug: gemcitabine hydrochloride
|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|
- Progression rate at 3 months [ Time Frame: 2012 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2012 ] [ Designated as safety issue: Yes ]
- Biliary complication rate [ Time Frame: 2012 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Radio-chimiothérapie
|Drug: gemcitabine hydrochloride Drug: oxaliplatin|
- 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)
- 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.
|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|
|Paris, France, 75651|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|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|
|Principal Investigator:||Bruno Chauffert||Centre de Lutte Contre le Cancer Georges-Francois Leclerc|