Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery
- Conditions
- Extrahepatic Bile Duct CancerGallbladder CancerLiver Cancer
- Interventions
- Other: clinical observationProcedure: adjuvant therapyProcedure: quality-of-life assessment
- Registration Number
- NCT01313377
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery.
PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* Compare disease-free survival (DFS) of patients with resected biliary tract cancer treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical observation.
* Compare quality of life of these patients.
Secondary
* Compare overall survival of these patients.
* Determine the toxicity of the chemotherapy in these patients.
* Explore prognostic factors for DFS including resection result (R0 vs R1), location of primary tumor (intrahepatic vs extrahepatic vs gallbladder), evolution of CA19-9, and lymph node involvement (N0 vs N+ and Nx). (Exploratory)
* Study pathological factors in surgical specimens to identify main characteristics and phenotypic clinicoanatomical biliary tract cancers before therapy. (Exploratory)
* Identify nontumor-associated liver injury and factors that may facilitate the emergence of biliary tract cancers. (Exploratory)
* Identify signaling pathways that may predict response to therapy. (Exploratory)
* Determine the molecular characteristics to differentiate tumors according to their position in the biliary tract (extrahepatic bile duct, intrahepatic cholangiocarcinoma site \[hilar\], and peripheral cholangiocarcinoma vesicle site). (Exploratory)
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 12 courses.
* Arm II: Patients undergo clinical observation only every 4 weeks for 5 months. Quality of life is assessed at baseline, at 3 and 6 months, and then at all follow-up visits.
After completion of study therapy, patients are followed up at 6 months, every 3 months for 2 years, and then every 6 months for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM A: Gemox 85 gemcitabine hydrochloride Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85) ARM A: Gemox 85 oxaliplatin Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85) ARM A: Gemox 85 adjuvant therapy Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85) ARM A: Gemox 85 quality-of-life assessment Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85) ARM B: clinical observation Observation until progression or death ARM B: quality-of-life assessment Observation until progression or death
- Primary Outcome Measures
Name Time Method Disease-free survival up to 3 years Quality of life up to 3 years
- Secondary Outcome Measures
Name Time Method Overall survival up to 3 years Toxicity of adjuvant chemotherapy up to 3 years
Trial Locations
- Locations (37)
Hôpital Jean Minjoz
🇫🇷Besancon, France
Hôpital Saint Joseph
🇫🇷Marseille, France
Hôpital Nord
🇫🇷Marseille, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hôpital Beaujon
🇫🇷Clichy, France
Centre Paul Papin
🇫🇷Angers, France
CHU - Hôpital Nord
🇫🇷Amiens, France
Institut Sainte Catherine
🇫🇷Avignon, France
Hôpital Avicenne
🇫🇷Bobigny, France
Centre hospitalier de la Côte Basque
🇫🇷Bayonne, France
CHU Côte de Nacre
🇫🇷Caen, France
CHD Vendée
🇫🇷La Roche Sur Yon, France
CHU Brest - Hôpital Morvan
🇫🇷Brest, France
CHU Estaing
🇫🇷Clermont Ferrand, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Hôpital Bocage
🇫🇷Dijon, France
Centre Léon Bérard
🇫🇷Lyon, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Centre Hospitalier Saint Eloi
🇫🇷Montpellier, France
Centre René Gauducheau
🇫🇷Nantes, France
Hôpital La Source
🇫🇷Orléans, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Centre Eugene Marquis
🇫🇷Rennes, France
CHU de Rouen - Hôpital Ch. Nicolle
🇫🇷Rouen, France
CHU de Poitiers
🇫🇷Poitiers, France
CHU Sainte-Etienne - Hopital Nord
🇫🇷Sainte-Etienne, France
CHU Brabois
🇫🇷Vandouevre Les Nancy, France
Hôpital Trousseau
🇫🇷Tours, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Hôpital de Hautepierre / Hôpital Civil
🇫🇷Strasbourg, France
CHU Saint Louis
🇫🇷Paris, France
Hôpital de la Pitié Salpétrière
🇫🇷Paris, France
CHU Timone Adulte
🇫🇷Marseille, France
Hôpital Saint Antoine
🇫🇷Paris, France
Institut Mutualiste Montsouris
🇫🇷Paris, France