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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01526135
First received: February 1, 2012
Last updated: October 16, 2014
Last verified: October 2014
  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®) 180 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®) 180 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
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 70 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: Trevor V STANBURY, PhD +33(1)44235567 t-stanbury@unicancer.fr

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Scott Dowden, Dr       scot.dowden@albertahealthservices.ca   
Principal Investigator: Scott Dowden, Dr         
Canada, British Columbia
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Daniel J Renouf, Dr       drenouf@bccancer.bc.ca   
Principal Investigator: Daniel J Renouf, Dr         
Canada, Manitoba
CancerCare Manitoba, St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Ralph Wong, Dr       ralph.wong@cancercare.mb.ca   
Principal Investigator: Ralph Wong, Dr         
Canada, New Brunswick
Dr Leon Richard Oncology Centre Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Eve St-Hilaire, Dr       eve.st-hilaire@vitalitenb.ca   
Principal Investigator: Eve St-Hilaire, Dr         
Canada, Ontario
The Royal Victoria Hospital - Cancer Care Program Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Bryn Pressnail, Dr       pressnailb@rvh.on.ca   
Principal Investigator: Bryn Pressnail, Dr         
Juravinski Cancer centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Elaine McWhirter, Dr       elaine.mcwhirter@jcc.hhsc.ca   
Principal Investigator: Elaine McWhirter, Dr         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: James Biagi, Dr       jim.biagi@krcc.on.ca   
Principal Investigator: James Biagi, Dr         
Ottawa Health Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Christine Cripps, Dr       ccripps@toh.on.ca   
Principal Investigator: Christine Cripps, Dr         
Niagara Health System Recruiting
St. Catharines, Ontario, Canada, L2S 0A9
Contact: Brian Findlay, Dr       brian.findlay@niagarahealth.on.ca   
Principal Investigator: Brian Findlay, Dr         
Department of Medical Oncology Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Pablo Cano, Dr       pcano@hrsrh.on.ca   
Principal Investigator: Pablo Cano, Dr         
General Surgery - TGH Site, Univ. Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Alice C Wei, Dr       alice.wei@uhn.on.ca   
Principal Investigator: Alice C Wei, Dr         
Canada, Quebec
McGill University (Department of Oncology) Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Petr Kavan, Dr       petr.kavan@muhc.mcgill.ca   
Principal Investigator: Petr Kavan, Dr         
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Francine Aubin, Dr       francine.aubin.chum@ssss.gouv.qc.ca   
Principal Investigator: Francine Aubin, Dr         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Frederic Lemay, Dr       frederic.lemay@usherbrooke.ca   
Principal Investigator: Frederic Lemay, Dr         
Canada, Saskatchewan
Allain Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Haji Chalchal, Dr       haji.chalchal@saskcancer.ca   
Principal Investigator: Haji Chalchal, Dr         
Saskatoon Cancer Centre, University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Shahid Ahmed, Dr       shahid.ahmed@saskcancer.ca   
Principal Investigator: Shahid Ahmed, Dr         
Canada
The Moncton Hospital Recruiting
Moncton, Canada, E1C 6Z8
Contact: Mohammed Harb, Dr       dr.mohammed.harb@horizonnb.ca   
Principal Investigator: Mohammed Harb, Dr         
CHUQ - Hotel-Dieu de Quebec Recruiting
Quebec, Canada, G1R 2J6
Contact: Felix Couture, Dr       felixcou@videotron.ca   
Principal Investigator: Felix Couture, Dr         
Algoma District Cancer Program, Sault Area Hospital Recruiting
Sault Ste. Marie, Canada, P6B 0A8
Contact: Mohammad Rassouli, Dr       rassoulim@sah.on.ca   
Principal Investigator: Mohammad Rassouli, Dr         
France
ICO Paul Papin Recruiting
Angers, France
Principal Investigator: VERONIQUE GUERIN-MEYER         
Institut Bergonié Recruiting
Bordeaux, France
Principal Investigator: YVES BECOUARN         
Centre Léon Bérard Recruiting
Lyon, France
Principal Investigator: CHRISTELLE de La FOUCHARDIERE         
Institut Paoli Calmettes Recruiting
Marseille, France
Principal Investigator: J-L RAOUL         
CRCL Val d'Aurelle Recruiting
Montpellier, France
Principal Investigator: MARC YCHOU         
Centre Antoine-Lacassagne Recruiting
Nice, France
Principal Investigator: ERIC FRANCOIS         
Centre René Gauducheau Recruiting
Saint Herblain, France
Principal Investigator: JAAFAR BENNOUNA         
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Thierry CONROY, PROF Centre Alexis Vautrin-VANDOEUVRE LES NANCY
  More Information

No publications provided

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: October 16, 2014
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, Ductal, Breast
Breast Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases
Gemcitabine
Irinotecan
Oxaliplatin
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors

ClinicalTrials.gov processed this record on October 30, 2014