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Spots Global Cancer Trial Database for Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

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Trial Identification

Brief Title: Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

Official Title: Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts

Study ID: NCT01313377

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU - Hôpital Nord, Amiens, , France

Centre Paul Papin, Angers, , France

Institut Sainte Catherine, Avignon, , France

Centre hospitalier de la Côte Basque, Bayonne, , France

Hôpital Jean Minjoz, Besancon, , France

Hôpital Avicenne, Bobigny, , France

CHU Brest - Hôpital Morvan, Brest, , France

CHU Côte de Nacre, Caen, , France

CHU Estaing, Clermont Ferrand, , France

Hôpital Beaujon, Clichy, , France

Hôpital Henri Mondor, Créteil, , France

Hôpital Bocage, Dijon, , France

CHD Vendée, La Roche Sur Yon, , France

Centre Léon Bérard, Lyon, , France

Hôpital Privé Jean Mermoz, Lyon, , France

Hôpital Edouard Herriot, Lyon, , France

Hôpital Saint Joseph, Marseille, , France

Hôpital Nord, Marseille, , France

Institut Paoli Calmettes, Marseille, , France

CHU Timone Adulte, Marseille, , France

Centre Hospitalier Saint Eloi, Montpellier, , France

Centre René Gauducheau, Nantes, , France

Hôpital La Source, Orléans, , France

Hôpital Saint Antoine, Paris, , France

Institut Mutualiste Montsouris, Paris, , France

CHU Saint Louis, Paris, , France

Hôpital de la Pitié Salpétrière, Paris, , France

Hôpital Européen Georges Pompidou, Paris, , France

CHU de Poitiers, Poitiers, , France

Centre Eugene Marquis, Rennes, , France

CHU de Rouen - Hôpital Ch. Nicolle, Rouen, , France

CHU Sainte-Etienne - Hopital Nord, Sainte-Etienne, , France

Centre Paul Strauss, Strasbourg, , France

Hôpital de Hautepierre / Hôpital Civil, Strasbourg, , France

Hôpital Trousseau, Tours, , France

CHU Brabois, Vandouevre Les Nancy, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Eveline Boucher, MD

Affiliation: Centre Eugene Marquis

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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