Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02172976|
Recruitment Status : Recruiting
First Posted : June 24, 2014
Last Update Posted : April 8, 2016
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 6 cycles FOLFIRINOX followed by surgery followed by 6 cycles FOLFIRINOX.
The overall survival between both therapies will be compared as well as other parameters.
|Condition or disease||Intervention/treatment||Phase|
|Resectable Prancreas Carcinoma||Drug: Gemcitabine Drug: Oxaliplatin Drug: 5-Fluorouracil Drug: Irinotecan Drug: Natriumfolinate||Phase 2 Phase 3|
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 (6 cycles FOLFIRINOX neoadjuvant, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Oxaliplatin 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: Gemcitabine
Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery
- median overall survival [ Time Frame: From date of randomization until the date of death from any cause assessed up to 24 months ]
- median progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression / relapse or date of death from any cause, whichever came first, assessed up to 24 months ]
- perioperative morbidity and mortality [ Time Frame: 30 days after surgery ]
- R0 resection rate [ Time Frame: 2 months after surgery ]
- pathological complete remission [ Time Frame: at surgery ]during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards
- adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm [ Time Frame: up to 40 weeks ]
- prevalence of iron deficiency [ Time Frame: baseline, d1 of every cycle, end of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172976
|Contact: Salah-Eddin Al-Batran, Prof.||+firstname.lastname@example.org|
|Contact: Claudia Pauligk, PhDemail@example.com|
|Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany||Recruiting|
|Frankfurt, Germany, 60488|
|Contact: Alexander Reichart, MD +496976014350|
|Contact: Claudia Pauligk +496976013906 firstname.lastname@example.org|
|Principal Investigator:||Alexander Reichart, Dr.||Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany|