Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX For Resectable Pancreas Carcinoma

Study Overview

Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma

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.

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.

Resectable Prancreas Carcinoma

DRUG: Gemcitabine
DRUG: Oxaliplatin
DRUG: 5-Fluorouracil
DRUG: Irinotecan
DRUG: Natriumfolinate

NEPAFOX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-09-01
First Submitted that Met QC Criteria 2014-06-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-09-02
First Posted (ACTUAL) 2014-06-24	Results First Posted N/A	Last Verified 2020-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRINOX 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	DRUG: Oxaliplatin DRUG: 5-Fluorouracil DRUG: Irinotecan DRUG: Natriumfolinate
ACTIVE_COMPARATOR: Gemcitabine Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery	DRUG: Gemcitabine

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRINOX

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

DRUG: Oxaliplatin

DRUG: 5-Fluorouracil

DRUG: Irinotecan

DRUG: Natriumfolinate

ACTIVE_COMPARATOR: Gemcitabine

Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery

DRUG: Gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
median overall survival		From date of randomization until the date of death from any cause assessed up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
median progression-free survival (PFS)		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		30 days after surgery
R0 resection rate		2 months after surgery
pathological complete remission	during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards	at surgery
adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm		up to 40 weeks
prevalence of iron deficiency		baseline, d1 of every cycle, end of treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Salah-Eddin Al-Batran, Prof., Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record