Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone
- Compare the overall survival of patients with nonresectable, nonmetastatic
adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without
fluorouracil, cisplatin, and radiotherapy followed by gemcitabine hydrochloride.
- Compare the toxicities of these regimens in these patients.
- Compare the objective response (complete, partial, or stable) in patients treated with
- Compare the clinical benefit, in terms of general condition and weight maintenance in
patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO
performance status (0 or 1 vs 2), initial treatment (laparotomy with or without
bilio-digestive diversion) (yes vs no), and peritoneal cytology (positive vs negative).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV over 15 minutes on days 1-5 and 29-33 and
fluorouracil IV continuously on days 1-40. Patients also undergo radiotherapy daily, 5
days a week, for 6 weeks.
- Arm II: Patients receive gemcitabine hydrochloride IV over 15 minutes on day 1.
Treatment repeats every 7 days for 7 weeks.
Beginning in week 11 of arm I or week 9 of arm II, patients receive gemcitabine
hydrochloride IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for
up to 10 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 190 patients will be accrued for this trial.
Allocation: Randomized, Primary Purpose: Treatment
Francoise Mornex, MD, PhD
Centre Hospitalier Lyon Sud
United States: Federal Government