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

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ClinicalTrials.gov Identifier: NCT01526135
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : January 4, 2022
Sponsor:
Collaborator:
Canadian Cancer Trials Group
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE February 1, 2012
First Posted Date  ICMJE February 3, 2012
Last Update Posted Date January 4, 2022
Actual Study Start Date  ICMJE April 16, 2012
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
disease-free survival (DFS) [ Time Frame: 3 YEARS ]
to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
  • Overall survival [ Time Frame: 36 MONTHS ]
  • Specific survival [ Time Frame: 36 MONTHS ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
Official Title  ICMJE Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Intervention  ICMJE
  • Drug: mFolfirinox

    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)

  • Drug: Gemcitabine
    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
Study Arms  ICMJE
  • Active Comparator: Arm A GEMCITABINE
    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: Drug: Gemcitabine
  • Experimental: Arm B mFOLFIRINOX

    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: Drug: mFolfirinox
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2019)
493
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2012)
490
Actual Study Completion Date  ICMJE July 16, 2021
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01526135
Other Study ID Numbers  ICMJE Prodige 24 / Accord 24
NCIC CTG PA.6 ( Other Identifier: NCIC )
2011-002026-52 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UNICANCER
Original Responsible Party Same as current
Current Study Sponsor  ICMJE UNICANCER
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Canadian Cancer Trials Group
Investigators  ICMJE
Principal Investigator: Thierry CONROY, PROF Centre Alexis Vautrin-VANDOEUVRE LES NANCY
PRS Account UNICANCER
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP