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

Sponsor

Federation Francophone de Cancerologie Digestive (Other)

Overall Status

Completed

CT.gov ID

NCT00304135

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Drug: oxaliplatin	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Radio-chimiothérapie Radio-chimiothérapie	Drug: cisplatin
Experimental: GEMOX GEMOX	Drug: gemcitabine hydrochloride Drug: oxaliplatin

Arm

Intervention/Treatment

Active Comparator: Radio-chimiothérapie

Radio-chimiothérapie

Drug: cisplatin

Experimental: GEMOX

GEMOX

Drug: gemcitabine hydrochloride

Drug: oxaliplatin

Outcome Measures

Primary Outcome Measures

Progression rate at 3 months [2012]
Overall survival [2012]

Secondary Outcome Measures

Toxicity [2012]
Biliary complication rate [2012]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier General	Belfort	France	90000
2	Centre Hospitalier Pierre Oudot	Bourgoin-Jallieu	France	38300
3	Hopital Louis Pasteur	Colmar	France	68024
4	Centre Hospitalier de Dax	Dax	France	40100
5	Hopital Du Bocage	Dijon	France	21034
6	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon	France	21079
7	Centre Hospitalier Departemental	La Roche Sur Yon	France	F-85025
8	C. H. Du Mans	Le Mans	France	72037
9	CHU de la Timone	Marseille	France	13385
10	Centre Hospitalier General de Mont de Marsan	Mont-de-Marsan	France	40000
11	CHR D'Orleans - Hopital de la Source	Orleans	France	45100
12	Hopital Bichat - Claude Bernard	Paris	France	75018
13	CHU Pitie-Salpetriere	Paris	France	75651
14	Centre Hospitalier Lyon Sud	Pierre Benite	France	69495
15	Hopital Sebastopol, C.H.U. de Reims	Reims	France	51092
16	Centre Eugene Marquis	Rennes	France	35062
17	Hopital Charles Nicolle	Rouen	France	76031
18	Centre Hospitalier de Semur en Auxois	Semur en Auxois	France	21140
19	Hopital Universitaire Hautepierre	Strasbourg	France	67098
20	Centre Hospitalier de Tarbes	Tarbes	France	65013