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:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00304135
First received: March 15, 2006
Last updated: March 3, 2014
Last verified: December 2006
  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:


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 and older
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

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
CHU Pitie-Salpetriere
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
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Bruno Chauffert Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

Additional Information:
No publications provided

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: March 3, 2014
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
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Gemcitabine
Oxaliplatin
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014