Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
- Sponsor
- Krankenhaus Nordwest
- Study ID
- NCT02172976
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Resectable Prancreas Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Gemcitabine — DRUG
- Oxaliplatin — DRUG
- 5-Fluorouracil — DRUG
- Irinotecan — DRUG
- Natriumfolinate — DRUG
Study Details
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX. The overall survival between both therapies will be compared as well as other parameters.
Key Dates
- Start date
- Nov 30, 2014
- Status verified
- Sep 2020
- Primary completion
- Jan 31, 2020
- Completion
- May 31, 2020
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: FOLFIRINOXOxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery
- Active Comparator: GemcitabineGemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery
Primary Outcome Measure
median overall survival [ Time Frame: From date of randomization until the date of death from any cause assessed up to 24 months ]