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.

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2017

At a glance

  • Drugs Gemcitabine (Primary) ; Oxaliplatin (Primary)
  • Indications Biliary cancer; Gallbladder cancer
  • Focus Therapeutic Use
  • Acronyms PRODIGE 12
  • Most Recent Events

    • 21 Jan 2017 Results assessing relapse free survival, safety and health-related quality of life (HrQoL), presented at the 2017 Gastrointestinal Cancers Symposium.
    • 30 Jun 2016 Treatment arms changed from 1 to 2 and adjuvant chemotherapy for six months with gemcitabine added in treatment.
    • 30 Jun 2016 Status changed from recruiting to completed.
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