Clinical trialPhase 2Completed
Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- May 2002
- Expected end
- December 2010
- Enrollment
- 29 participants
- Sites
- 1
- Primary outcomes
- Median Overall Survival (OS)
- Sponsor
- Other
- Results posted
- 2012-02-14
- Last update
- 15 February 2012
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Brief summary public domain (ClinicalTrials.gov)
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy. * Determine the toxic effects of this regimen in these patients. Secondary * 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. OUTLINE: * 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 fractions). * 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Median Overall Survival (OS) [Participants followed till disease progression or death (approximately 6 years)]. Median, months (95% Confidence Interval). Postoperative Chemoradiation Regimen (n=28): 42 (32.1 to 64.5).