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

March 15, 2006
March 3, 2014
October 2005
December 2012   (final data collection date for primary outcome measure)
  • Progression rate at 3 months [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00304135 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: 2012 ] [ Designated as safety issue: Yes ]
  • Biliary complication rate [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Drug: oxaliplatin
  • Active Comparator: Radio-chimiothérapie
    Radio-chimiothérapie
    Intervention: Drug: cisplatin
  • Experimental: GEMOX
    GEMOX
    Interventions:
    • Drug: gemcitabine hydrochloride
    • Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00304135
CDR0000470411, FFCD-9902, SANOFI-FFCD-9902, LILLY-FFCD-9902, FFCD-FNCLCC-SFRO-9902
Yes
Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
Not Provided
Principal Investigator: Bruno Chauffert Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Federation Francophone de Cancerologie Digestive
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP