Status: Closed
Activation Date: 2012JUL17
Closing Date: 2016SEP07
Phase: III
Description: Multicentre Randomized Phase III Trial Comparing 6-Month Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) In Patients With Resected Pancreatic Adenocarcinoma
Eligibility: Inclusion Criteria:- Histologically proven pancreatic ductal adenocarcinoma, Macroscopically complete resection (R0 or R1 resection), Patients aged from 18 to 79 years, Performance status 0-1, - No prior radiotherapy and no previous chemotherapy, No heart failure or coronary heart disease symptoms,Satisfactory postoperative recovery and patient able to receive chemotherapy,adequate oral nutrition of at least 1500 calories per day, free of significant nausea and vomiting,adequate hematologic function, Adequate liver function (bilirubin . 1.5 xUNL), Creatinine clearance > 50 mL/min, interval since the surgery between 21 and 84 days, patient information and signed informed consent. Exclusions: Non ductal adenocarcinoma of the pancreas (eg endocrine, acinar cell, cystadenocarcinoma and ampulloma), Metastases (including ascites or pleural malignant effusion), macroscopic incomplete tumour resection (R2), CA 19-9> 180u/ML within 21 day prior to randomization, concurrent/prior other cancer.
Objective: Primary: Disease-Free Survival Secondary: Overall Survival
Participation: Open to member centres
Lay Description: The purpose of this study is to find out whether standard treatment with gemcitabine or combination treatment with 5-fluorouricil, leucovorin, irinotecan and oxaliplatin (mFOLFIRINOX) is better at preventing pancreatic cancer that has been sugically removed from coming back.To do this, half of the patients in this study will get gemcitabine and the other half will receive combination chemotherapy (mFOLFIRINOX). You will know what treatment you will get and both treatments last approximately 6 months.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | PA6 | 93 | 0 | 65 | 65 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | PA6 | 93 | 1 | 47 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | PA6 | 93 | 9 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |