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NCT01526135 · CITED IN SOURCE DOCUMENTS

Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2022-01-04

This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. Histologically proven pancreatic ductal adenocarcinoma. Intraductal papillary mucinous tumor of the pancreas (IPMT) with invasive components are eligible. 2. Macroscopically complete resection (R0 or R1 resection). 3. Patients aged from 18 to 79 years. 4. WHO performance status 0-1. 5. No prior radiotherapy and no previous chemotherapy. 6. Full recovery from surgery and patient able to receive chemotherapy: adequate oral nutrition of ≥1500 calories per day and free of significant nausea and vomiting. 7. Adequate hematologic function (Absolute neutrophil count ANC ≥1,500 cells/mm³, platelets ≥100 000 cells/mm³ and hemoglobin ≥10 g/L - possibly after transfusion -). 8. Serum total bilirubin ≤1.5 times the institutional upper limit of normal. 9. Creatinine level \<130 micromol/L (14.7 mg/L). 10. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men. 11. Interval since surgery between 21 and 84 days. 12. Patient information and signed informed consent. 13. Public or private health insurance coverage. Exclusion Criteria: 1. Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and malignant ampulloma. 2. Metastases (including ascites or malignant pleural effusion). 3. Macroscopic incomplete tumor removal (R2 resection). 4. CA 19-9 \> 180 U/ml within 21 days of registration on study. 5. No heart failure or coronary heart disease symptoms. 6. No major comorbidity that may preclude the delivery of treatment or active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes. 7. Pre-existing neuropathy, Gilbert's disease or genotype UGT1A1 \* 28 / \* 28. 8. Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea. 9. Concomitant occurrence of another cancer, or history of cancer except in situ carcinoma of the cervix treated or basal cell carcinoma or squamous cell carcinoma. 10. Fructose intolerance. 11. Persons deprived of liberty or under guardianship. 12. Psychological, familial, sociological or geographical condition potentially. hampering compliance with the study protocol and follow-up schedule.
healthy Volunteers
false
maximum Age
79 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Arm A : Gemcitabine 1000 mg/m² IV infusion over 30 minutes, weekly, during 3 weeks + 1 week of rest (= 1 cycle) repeated 6 times (i.e., 6 cycles) during 24 weeks
    intervention Names
    1. Drug: Gemcitabine
    label
    Arm A GEMCITABINE
    type
    ACTIVE_COMPARATOR
  2. description
    Arm B : mFOLFIRINOX every 14 days, 12 cycles, 24 weeks. Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started. Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours. 5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day)
    intervention Names
    1. Drug: mFolfirinox
    label
    Arm B mFOLFIRINOX
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm B mFOLFIRINOX
    description
    mFolfirinox every 14 days, 12 cycles, 24 weeks. mFolfirinox : Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started. Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours. 5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day)
    name
    mFolfirinox
    type
    DRUG
  2. arm Group Labels
    1. Arm A GEMCITABINE
    description
    Gemcitabine 1000 mg/m² IV infusion over 30 minutes, weekly, during 3 weeks + 1 week of rest (= 1 cycle) repeated 6 times (i.e., 6 cycles) during 24 weeks
    name
    Gemcitabine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
493
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
    measure
    disease-free survival (DFS)
    time Frame
    3 YEARS
secondary Outcomes
  1. measure
    Overall survival
    time Frame
    36 MONTHS
  2. measure
    Specific survival
    time Frame
    36 MONTHS
Full study description
brief Summary
This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.
detailed Description
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy The main criterion is the disease-free survival at 3 years. Disease-free survival is the time delay between the date of randomization and the date at which the 1st cancer-related event such as local relapse, distant metastasis, a second cancer or death from any cause is observed. Patients without event at the time of anlaysis will be censored at the date of last follow-up visit. Locoregional relapse is a disease relapse occurring at the site of primary resection, in the pancreas or in the associated regional lymph nodes. Metastatic relapse is the distant disease recurrence involving any possible sites of relapse (peritoneal, hepatic, pulmonary, and distant lymph nodes). Secondary criteria Overall and specific survival Overall survival is the time delay between the date of randomization and the patient's death, irrespective of its cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit. Specific survival is the time delay between the date of randomization and the patient's death due to the treated cancer or a treatment-related complication. Metastasis-free survival Metastasis-free survival is the time delay between the date of randomization and the date of the 1st distant event occurrence (peritoneal, hepatic, pulmonary, and lymph nodes). Loco-regional events will be discarded and patients still living without metastasis at the time of analysis will be censored at the date of last follow-up examination objectively assessing this type of event. Tolerance Patients evaluable for toxicity must have received at least one course or injection of the treatment.
Source references
references
  1. citation
    Conroy T, Castan F, Lopez A, Turpin A, Ben Abdelghani M, Wei AC, Mitry E, Biagi JJ, Evesque L, Artru P, Lecomte T, Assenat E, Bauguion L, Ychou M, Bouche O, Monard L, Lambert A, Hammel P; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Nov 1;8(11):1571-1578. doi: 10.1001/jamaoncol.2022.3829.
    pmid
    36048453
    type
    DERIVED
  2. citation
    Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
    pmid
    30575490
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        iv class="pdq-content-list"><ol id="_1888"><li>FOLFIRINOX: In the randomized, open-label, phase III <a href="/clinicaltrials/NCT01526135">PRODIGE-24</a> trial (NCT01526135), 493 patients with R0/R1 resections were randomly assigned 1:1 to receive six cycles of gemcitabine (1,000 mg/m<span class="sup">2</span> on days 1, 8, and 15
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      1. context
        Updated: February 12, 2025
        datetime
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        display
        February 12, 2025

    Preserved source evidence · Not medical advice