Clinical trialPhase 2 / Phase 3Completed
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 2 / Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- November 2014
- Expected end
- May 2020
- Enrollment
- 40 participants
- Sites
- 1
- Primary outcomes
- median overall survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 2 September 2020
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
This is a phase II/III randomized multicenter study. Patients with resectable pancreatic carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B (4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant). Primary endpoint is the overall survival, secondary endpoints are progression-free survival, perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of neoadjuvant FOLFIRINOX and others.
Papers 1
- Registry-listed results paperAdjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter… DOI 10.1245/s10434-024-15011-7↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.