A Randomized Phase III Trial Comparing Folfirinox To Gemcitabine In Locally Advanced Pancreatic Carcinoma

Study Overview

A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.

Comparative interventional prospective phase 3, randomized, open-label, multicentric trial comparing chemotherapy with Folfirinox to Gemcitabine in locally advanced pancreatic carcinoma.

Pancreatic Cancer
Carcinoma

DRUG: Gemcitabine
DRUG: Folinic Acid
DRUG: 5-Fluoro-uracil
DRUG: Oxaliplatin
DRUG: Irinotecan
DRUG: L-folinic

PRODIGE 29 (UCGI 26)
2014-003510-82 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

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 2015-08-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-08
First Submitted that Met QC Criteria 2015-08-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-09
First Posted (ACTUAL) 2015-09-03	Results First Posted N/A	Last Verified 2024-01

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
ACTIVE_COMPARATOR: Arm A: Gemcitabine Gemcitabine 1000 mg/m² IV infusion over 30 minutes on D1 of each week for the 4 weeks of the first cycle (1 cycle = 4 weeks). For the following five cycles, gemcitabine infusion on D1, D8, and D15 of each cycle, followed by 1 week without injection (i.e.	DRUG: Gemcitabine
EXPERIMENTAL: Arm B: Folfirinox Administered once every 14 days for 24 weeks (12 cycles). A cycle equals 14 days with injection on D1 of each cycle. Treatment starts with oxaliplatin (85 mg/m²) administration; IV infusion over 2 hours, followed by the simultaneous administration (using	DRUG: Folinic Acid DRUG: 5-Fluoro-uracil DRUG: Oxaliplatin DRUG: Irinotecan DRUG: L-folinic

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Arm A: Gemcitabine

Gemcitabine 1000 mg/m² IV infusion over 30 minutes on D1 of each week for the 4 weeks of the first cycle (1 cycle = 4 weeks). For the following five cycles, gemcitabine infusion on D1, D8, and D15 of each cycle, followed by 1 week without injection (i.e.

DRUG: Gemcitabine

EXPERIMENTAL: Arm B: Folfirinox

Administered once every 14 days for 24 weeks (12 cycles). A cycle equals 14 days with injection on D1 of each cycle. Treatment starts with oxaliplatin (85 mg/m²) administration; IV infusion over 2 hours, followed by the simultaneous administration (using

DRUG: Folinic Acid

DRUG: 5-Fluoro-uracil

DRUG: Oxaliplatin

DRUG: Irinotecan

DRUG: L-folinic

Primary Outcome Measures	Measure Description	Time Frame
Progression-Free-Survival (PFS)	To compare Progression-Free-Survival (PFS) between the two treatment arms	From randomization until disease progression or date of death, assessed up until to 128 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Composite index for treatment early severe toxicity	Biliary tract infection Grade 3-4 + any grade 5 toxicities + chemotherapy interruption for toxicity during the first four cycles.	First four chemotherapy cycles, 16 weeks
Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy	Observance of chemotherapy	During treatment phase, 24 weeks
Overall Survival	The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.	Until death, assessed up 128 weeks after randomization
Progression-free survival: pattern of failure	The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.	Until Disease Progression, assessed uo until 128 weeks after randomization
Percentage of secondarily curative-intent surgery	Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology.	Until surgery, if applicable, up until 128 weeks after randomization
Objective tumour response, disease control and their duration	Objective tumour response, disease control and their duration (RECIST version 1.1),	Until disease progression or date of death, assessed up until 128 weeks after randomization
Time to treatment failure	Time to treatment failure	From randomisation to the end of treatment
Quality of life questionnaire - Core 30 (QLQ-C30)	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	assessed up until 128 weeks after randomization

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:

Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
Hemoglobin ≥ 10 g/dL
Platelets (PTL) ≥ 75 x 10⁹/L
Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
Bilirubin ≤ 1.5 x ULN
Creatinine ≤ 2 x ULN
Albumin > 0.75 x lower limit of normal (LLN)
Urea ≤ 2 x ULN 8. Adequate vital functions 9. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use medically acceptable methods of contraception during the study and for 4 months after the last intake of study treatment for women and for 6 months after for men. 10. Patient information and signed informed consent form 11. Public or private health insurance coverage 12. Uracilemia < 16 ng/ml

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28 6. Pregnant woman 7. Fructose intolerance 8. Patients currently treated by warfarin 9. Persons deprived of liberty or under guardianship 10. Psychological condition, family-, sociological- or geographical situation potentially hampering compliance with the study protocol and the follow-up schedule

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Michel DUCREUX, Professor, Gustave Roussy, Cancer Campus, Grand Paris

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

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Clinical Trial Record