Clinical Trials /

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

NCT02539537

Description:

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

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
GemcitabineArm A: Gemcitabine
Folinic AcidArm B: Folfirinox
5-Fluoro-uracilArm B: Folfirinox
OxaliplatinArm B: Folfirinox
IrinotecanArm B: Folfirinox
L-folinicArm B: Folfirinox

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm A: GemcitabineActive ComparatorGemcitabine 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).
  • Gemcitabine
Arm B: FolfirinoxExperimentalAdministered 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 min. The irinotecan will begin 30 min. 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:
Measure:Progression-free survival: pattern of failure
Time Frame:Until Disease Progression, assessed uo until 128 weeks after randomization
Safety Issue:
Description:
Measure:Percentage of secondarily curative-intent surgery
Time Frame:Until surgery, if applicable, up until 128 weeks after randomization
Safety Issue:
Description:
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:Until disease progression, assessed up until 128 weeks after randomization
Safety Issue:
Description:
Measure:Quality of life (QLQ C30)
Time Frame:assessed up until 128 weeks after randomization
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UNICANCER

Trial Keywords

  • locally advanced pancreatic carcinoma
  • FOLFIRINOX

Last Updated

December 2, 2019