Status: Closed
Activation Date: 2001OCT31
Closing Date: 2008MAY06
Phase: III
Description: Phase III Adjuvant Trial In Pancreatic Cancer Comparing (1) 5FU And D-L Folinic Acid Vs (2) Gemcitabine Vs (3) No Adjuvant Treatment
Eligibility: Eligible patients have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection). Patients may also be included who have had complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) and (R0 or R1 resection)for(i) unusual malignancies of the pancreas such as ascinar cell carcinoma, cystadenocarcinoma, etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin.
Objective: This adjuvant study will test two hypotheses in a three arm study. A) Does either adjuvant gemcitabine or 5FU + folinic acid improve survival compared to no additional treatment following resection of pancreatic cancer. B) Is there any difference between gemcitabine and 5FU + folinic acid in terms of survival when used as adjuvant therapy following resection of pancreatic cancer. The primary endpoint is 2-year survival. Secondary endpoints will be toxicity, quality of life, and 5-year survival.
Participation: Open to member centres
Lay Description: The purpose of this study is to find out whether extra treatment with chemotherapy is better than surgery alone for people with the same type of cancer and if there is any difference between different types of treatment. This study will also compare the effects of the different types of treatment (5-FU and folinic acid vs. gemcitabine).
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | PA2 | 124 | 36 | 52 | 52 |
(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 | PA2 | 124 | 1 | 36 |
| 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 | PA2 | 124 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |