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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01526135
First received: February 1, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Drug: Arm B : mFolfirinox
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • disease-free survival (DFS) [ Time Frame: 3 YEARS ] [ Designated as safety issue: Yes ]
    to compare disease-free survival (DFS) at 3 years between the experimental and control arms.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 36 MONTHS ] [ Designated as safety issue: Yes ]
  • Specific survival [ Time Frame: 36 MONTHS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 490
Study Start Date: January 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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
Experimental: arm B mFolfirinox

Arm B : 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: Arm B : mFolfirinox

Arm B : 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)


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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526135

Contacts
Contact: Claire JOUFFROY, PharmD +33(1)71936366 c-jouffroy@unicancer.fr

  Show 52 Study Locations
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Thierry CONROY, PROF Centre Alexis Vautrin-VANDOEUVRE LES NANCY
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01526135     History of Changes
Other Study ID Numbers: Prodige 24 / Accord 24 
Study First Received: February 1, 2012
Last Updated: June 16, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by UNICANCER:
National multicentric phase III superiority trial

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Oxaliplatin
Gemcitabine
Irinotecan
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 27, 2016