Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
- Compare progression-free survival of patients with locally advanced, nonresectable
adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin
followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.
- Determine the tolerability of this regimen, in both the short- and long-term, in these
- Determine recurrence-free survival, overall survival, and response rate in patients
treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefits of this regimen in these patients.
- Determine locoregional and metastatic progression-free survival of patients treated
with this regimen.
OUTLINE: This is an open-label, multicenter study.
- Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and
oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in
the absence of disease progression or unacceptable toxicity. Patients are restaged at
day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease
proceed to chemoradiotherapy.
- Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients
also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour
on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable
Quality of life is assessed at baseline, at restaging, and at day 28 after completion of
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Laurence Moureau-Zabotto, MD
United States: Federal Government