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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Gemcitabine (Primary) ; Oxaliplatin (Primary)
  • Indications Adenocarcinoma; Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Therapeutic Use
  • Acronyms PRODIGE 12; PRODIGE 12-ACCORD 18-UNICANCER GI
  • Most Recent Events

    • 21 Sep 2020 Results of pooled analysis from two clinical trials: BCAT and PRODIGE 12 presented at the 45th European Society for Medical Oncology Congress
    • 01 Feb 2019 Results assessing whether gemcitabine and oxaliplatin chemotherapy (GEMOX) would increase relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who undergo resection, published in the Journal of Clinical Oncology.
    • 21 Jan 2017 Results assessing relapse free survival, safety and health-related quality of life (HrQoL), presented at the 2017 Gastrointestinal Cancers Symposium.
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