Status:
COMPLETED
Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Canadian Cancer Trials Group
Conditions:
Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- Histologically proven pancreatic ductal adenocarcinoma. Intraductal papillary mucinous tumor of the pancreas (IPMT) with invasive components are eligible.
- Macroscopically complete resection (R0 or R1 resection).
- Patients aged from 18 to 79 years.
- WHO performance status 0-1.
- No prior radiotherapy and no previous chemotherapy.
- 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.
- Adequate hematologic function (Absolute neutrophil count ANC ≥1,500 cells/mm³, platelets ≥100 000 cells/mm³ and hemoglobin ≥10 g/L - possibly after transfusion -).
- Serum total bilirubin ≤1.5 times the institutional upper limit of normal.
- Creatinine level \<130 micromol/L (14.7 mg/L).
- 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.
- Interval since surgery between 21 and 84 days.
- Patient information and signed informed consent.
- Public or private health insurance coverage.
Exclusion
- Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and malignant ampulloma.
- Metastases (including ascites or malignant pleural effusion).
- Macroscopic incomplete tumor removal (R2 resection).
- CA 19-9 \> 180 U/ml within 21 days of registration on study.
- No heart failure or coronary heart disease symptoms.
- No major comorbidity that may preclude the delivery of treatment or active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.
- Pre-existing neuropathy, Gilbert's disease or genotype UGT1A1 \* 28 / \* 28.
- Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea.
- 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.
- Fructose intolerance.
- Persons deprived of liberty or under guardianship.
- Psychological, familial, sociological or geographical condition potentially. hampering compliance with the study protocol and follow-up schedule.
Key Trial Info
Start Date :
April 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT01526135
Start Date
April 16 2012
End Date
July 16 2021
Last Update
January 4 2022
Active Locations (52)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
3
CancerCare Manitoba, St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
4
Dr Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3