Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
- Compare the 6-month progression-free survival rate in patients with unresectable
metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in
combination with either fluorouracil or cisplatin as first-line therapy.
- Compare the toxicity of these regimens in these patients.
- Compare the objective response rate in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6
weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.
- Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also
receive cisplatin IV weekly for 6 weeks.
In both arms, patients experiencing disease progression after completion of
chemoradiotherapy may receive additional courses of chemotherapy.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Progression-free survival rate at 6 months
Michel Ducreux, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government