Trial record 14 of 28 for:
Open Studies | "Bile Duct Neoplasms"
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fondation Francaise de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00304135
First received: March 15, 2006
Last updated: February 23, 2011
Last verified: December 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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:
Drug Information available for:
Fluorouracil
Cisplatin
Oxaliplatin
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression rate at 3 months [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Biliary complication rate [ Designated as safety issue: No ]
- Duration of hospitalization [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | October 2005 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304135
Locations
| France | |
| Centre Hospitalier General | Recruiting |
| Belfort, France, 90000 | |
| Contact: Serge Fratte, MD 33-384-574-095 sfratte@ch-montbeliard-belfort.rss.fr | |
| Centre Hospitalier Pierre Oudot | Recruiting |
| Bourgoin-Jallieu, France, 38300 | |
| Contact: Noel Stremsdoerfer, MD 33-4-7427-3011 | |
| Hopital Louis Pasteur | Recruiting |
| Colmar, France, 68024 | |
| Contact: Bernard Denis 33-3-8912-4097 | |
| Centre Hospitalier de Dax | Recruiting |
| Dax, France, 40100 | |
| Contact: Laure Gautier-Felizot 33-6-8591-9735 | |
| Hopital Du Bocage | Recruiting |
| Dijon, France, 21034 | |
| Contact: Laurent Bedenne, MD 33-3-8029-3750 lbedenne@u-bourgogne.fr | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Recruiting |
| Dijon, France, 21079 | |
| Contact: Bruno Chauffert 33-3-8073-7506 bchauffert@dijon.fnclcc.fr | |
| Centre Hospitalier Departemental | Recruiting |
| La Roche Sur Yon, France, F-85025 | |
| Contact: Roger Faroux 33-2-5144-6168 | |
| C. H. Du Mans | Recruiting |
| Le Mans, France, 72037 | |
| Contact: Marie-Aude Coulon 33-2-4343-4343 | |
| CHU de la Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Jean-Francois Seitz, MD 33-4-9138-6023 | |
| Centre Hospitalier General de Mont de Marsan | Recruiting |
| Mont-de-Marsan, France, 40000 | |
| Contact: Patrick Texereau, MD 33-5-5805-1164 | |
| CHR D'Orleans - Hopital de la Source | Recruiting |
| Orleans, France, 45100 | |
| Contact: Jean-Paul Lagasse 33-02-3651-4704 | |
| CHU Pitie-Salpetriere | Recruiting |
| Paris, France, 75651 | |
| Contact: Julien Taieb, MD 33-1-4216-1023 | |
| Hopital Bichat - Claude Bernard | Recruiting |
| Paris, France, 75018 | |
| Contact: Thomas Aparicio 33-1-4025-7200 thomas.aparicio@bch.ap-hop-paris.fr | |
| Centre Hospitalier Lyon Sud | Recruiting |
| Pierre Benite, France, 69495 | |
| Contact: Francoise Mornex, MD, PhD 33-478-864-253 francoise.mornex@chu-lyon.fr | |
| Hopital Sebastopol, C.H.U. de Reims | Recruiting |
| Reims, France, 51092 | |
| Contact: Stephanie Lagarde 33-326-784-410 | |
| Centre Eugene Marquis | Recruiting |
| Rennes, France, 35062 | |
| Contact: Eveline Boucher, MD 33-2-9925-3180 boucher@rennes.fnclcc.fr | |
| Hopital Charles Nicolle | Recruiting |
| Rouen, France, 76031 | |
| Contact: Pierre Michel 33-2-3288-8260 | |
| Centre Hospitalier de Semur en Auxois | Recruiting |
| Semur en Auxois, France, 21140 | |
| Contact: Patenotte 33-3-8089-6464 | |
| Hopital Universitaire Hautepierre | Recruiting |
| Strasbourg, France, 67098 | |
| Contact: Palascak 33-388-127-682 | |
| Centre Hospitalier de Tarbes | Recruiting |
| Tarbes, France, 65013 | |
| Contact: Glibert 33-5-6251-5151 | |
Sponsors and Collaborators
Fondation Francaise de Cancerologie Digestive
Investigators
| Principal Investigator: | Bruno Chauffert | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
Additional Information:
No publications provided
| 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: | February 23, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
localized unresectable adult primary liver cancer unresectable extrahepatic bile duct cancer unresectable gallbladder cancer |
Additional relevant MeSH terms:
|
Bile Duct Neoplasms Liver Neoplasms Gallbladder 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 May 19, 2013