Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery

Phase 2

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Liver Cancer; Gallbladder Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: cisplatin; Drug: oxaliplatin

• Registration Number: NCT00304135
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Status Verified: 2006-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEMOX	gemcitabine hydrochloride	GEMOX
Radio-chimiothérapie	cisplatin	Radio-chimiothérapie
GEMOX	oxaliplatin	GEMOX

Primary Outcome Measures

Name	Time	Method
Progression rate at 3 months	2012
Overall survival	2012

Secondary Outcome Measures

Name	Time	Method
Toxicity	2012
Biliary complication rate	2012

Trial Locations

Locations (20)

CHR D'Orleans - Hopital de la Source; 🇫🇷 Orleans, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Hopital Charles Nicolle; 🇫🇷 Rouen, France

Centre Hospitalier de Tarbes; 🇫🇷 Tarbes, France

Hopital Universitaire Hautepierre; 🇫🇷 Strasbourg, France

Centre Hospitalier General de Mont de Marsan; 🇫🇷 Mont-de-Marsan, France

C. H. Du Mans; 🇫🇷 Le Mans, France

Hopital Sebastopol, C.H.U. de Reims; 🇫🇷 Reims, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Hopital Louis Pasteur; 🇫🇷 Colmar, France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Hospitalier Departemental; 🇫🇷 La Roche Sur Yon, France

Hopital Bichat - Claude Bernard; 🇫🇷 Paris, France

CHU de la Timone; 🇫🇷 Marseille, France

Hopital Du Bocage; 🇫🇷 Dijon, France

Centre Hospitalier General; 🇫🇷 Belfort, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Centre Hospitalier Pierre Oudot; 🇫🇷 Bourgoin-Jallieu, France

Centre Hospitalier de Dax; 🇫🇷 Dax, France

Centre Hospitalier de Semur en Auxois; 🇫🇷 Semur en Auxois, France