Description:
French national multicentric phase III trial evaluating chemotherapy with Folfirinox or
gemcitabine in locally advanced pancreatic carcinoma.
Title
- Brief Title: A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
- Official Title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
PRODIGE 29 (UCGI 26)
- SECONDARY ID:
2014-003510-82
- NCT ID:
NCT02539537
Conditions
- Pancreatic Cancer
- Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Gemcitabine | | Arm A: Gemcitabine |
Folinic Acid | | Arm B: Folfirinox |
5-Fluoro-uracil | | Arm B: Folfirinox |
Oxaliplatin | | Arm B: Folfirinox |
Irinotecan | | Arm B: Folfirinox |
L-folinic | | Arm B: Folfirinox |
Purpose
French national multicentric phase III trial evaluating chemotherapy with Folfirinox or
gemcitabine in locally advanced pancreatic carcinoma.
Detailed Description
Comparative interventional prospective phase 3, randomized, open-label, multicentric trial
comparing chemotherapy with Folfirinox to Gemcitabine in locally advanced pancreatic
carcinoma.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Gemcitabine | Active Comparator | 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. in total 4 cycles over 24 weeks; with 19 administrations of Gemcitabine). | |
Arm B: Folfirinox | Experimental | 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 a Y-tubing) of folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours and irinotecan 180 mg/m² IV infusion over 90 minutes. The irinotecan will begin 30 minutes after the start of the folinic acid infusion.
5-Fluoro-uracil (5-FU) IV 2,400 mg/m²/h will be administered over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m²/day for the duration of 2 days.
Treatment will be continued for 24 weeks (12 cycles). | - Folinic Acid
- 5-Fluoro-uracil
- Oxaliplatin
- Irinotecan
- L-folinic
|
Eligibility Criteria
Inclusion Criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Proven unresectability after multidisciplinary discussion involving radiologist and a
surgeon
3. Locally advanced (i.e.: no metastasis or suspicion of metastasis) and unresectable
tumors: for example mesenteric or portal vein involvement, or > 180° encasement of the
superior mesenteric artery, or celiac abutment (NCCN 2012 criteria)
4. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques
or ≥ 10 mm with spiral CT scan according RECIST 1.1
5. WHO Performance status (PS) 0-1
6. Age ≥18 years
7. Patient with organ function as follows:
- 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
Exclusion Criteria:
1. Patient treated for a cancer other than pancreatic cancer within 5 years before
enrolment, with the exception of basal cell carcinoma or in situ cervical cancer
2. Patient with metastasis or with history of metastasis
3. Patient with grade III/IV cardiac problems as defined by the New York Heart
Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6
months before baseline)
4. Major comorbidity, active infection (HIV or chronic hepatitis B or C) or uncontrolled
diabetes that may preclude the delivery of the treatment
5. Pre-existing neuropathy (Grade ≥ 2), Gilbert's disease or genotype UGT1A1 * 28 / * 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free-Survival (PFS) |
Time Frame: | From randomization until disease progression or date of death, assessed up until to 128 weeks |
Safety Issue: | |
Description: | To compare Progression-Free-Survival (PFS) between the two treatment arms |
Secondary Outcome Measures
Measure: | Composite index for treatment early severe toxicity |
Time Frame: | First four chemotherapy cycles, 16 weeks |
Safety Issue: | |
Description: | Biliary tract infection Grade 3-4 + any grade 5 toxicities + chemotherapy interruption for toxicity during the first four cycles. |
Measure: | Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy |
Time Frame: | During treatment phase, 24 weeks |
Safety Issue: | |
Description: | Observance of chemotherapy |
Measure: | Overall Survival |
Time Frame: | Until death, assessed up 128 weeks after randomization |
Safety Issue: | |
Description: | 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. |
Measure: | Progression-free survival: pattern of failure |
Time Frame: | Until Disease Progression, assessed uo until 128 weeks after randomization |
Safety Issue: | |
Description: | 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. |
Measure: | Percentage of secondarily curative-intent surgery |
Time Frame: | Until surgery, if applicable, up until 128 weeks after randomization |
Safety Issue: | |
Description: | Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology. |
Measure: | Objective tumour response, disease control and their duration |
Time Frame: | Until disease progression or date of death, assessed up until 128 weeks after randomization |
Safety Issue: | |
Description: | Objective tumour response, disease control and their duration (RECIST version 1.1), |
Measure: | Time to treatment failure |
Time Frame: | From randomisation to the end of treatment |
Safety Issue: | |
Description: | Time to treatment failure |
Measure: | Quality of life questionnaire - Core 30 (QLQ-C30) |
Time Frame: | assessed up until 128 weeks after randomization |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | UNICANCER |
Trial Keywords
- locally advanced pancreatic carcinoma
- FOLFIRINOX
Last Updated
March 24, 2021