A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma
- Determine the overall survival of patients with previously resected pancreatic
adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and
- Determine the toxic effects of this regimen in these patients.
- Determine the disease-specific, biochemical failure-free, and symptom/treatment-free
survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Chemoradiotherapy: Patients receive fluorouracil intravenous (IV) continuously and
interferon alfa subcutaneously (SQ) 3 times per week (total of 17 doses) on days 1-19
and 29-45 and cisplatin IV over 6 hours on days 1, 8, 15, 29, 36 and 43. Patients also
undergo concurrent radiotherapy once daily, 5 days a week in weeks 1-3 and 5-7 (28
- Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on
days 71-108 and 127-168.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Overall Survival (OS)
Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.
Participants followed till disease progression or death (approximately 6 years)
Peter W. Pisters, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|