Chemotherapy and Radiation Following Pancreatic Surgery
To describe the overall survival and disease-free survival in pancreatic cancer patients treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon alpha followed by gemcitabine.
To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers.
|Pancreatic Cancer||Procedure: Pancreatic Surgery Radiation: Radiation therapy Drug: Cisplatin Drug: 5-FU Drug: Alpha-interferon Drug: Gemcitabine||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Adjuvant Chemoradiation Following Pancreatic Resection For Adenocarcinomas Of The Pancreas Using 3-D Conformal Radiation With Cisplatin, 5FU, And Alpha-Interferon As Radiosensitizing Agents Followed By Gemcitabine|
- To describe the overall survival and disease-free survival [ Time Frame: 2 years ]
- To describe the toxicities associated with adjuvant chemoradiation with cisplatin, 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers. [ Time Frame: Week 15 ]
|Study Start Date:||May 2002|
|Study Completion Date:||February 2009|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Surgery (pancreaticoduodenectomy, either standard or pylorus-preserving, with either standard or extended lymph node dissection, with or without portal vein resection) should occur at 8 weeks (plus or minus 2, not to exceed 10)
Radiation therapy will occur 8 weeks (plus or minus 2, not to exceed 10) postoperatively. Daily dose of 1.8 Gy five days per week. The first 45 Gy will be given to planning target volume 1. After 45 Gy, portals will be reduced to encompass planning target volume 2. The boost dose will be 5.4 Gy.
Cisplatin IV 25 mg/m2 on days 1, 8, 15, 22, 29, and 36 during radiation.
5-FU CIVI at 175 mg/m2/d on days 1-38 without interruption during radiation.
Alpha-interferon SQ 3,000,000 units on Mondays, Wednesdays, and Fridays during radiation therapy.
Gemcitabine IV 1000 mg/m2 4 weeks after conclusion of radiation (on a 3 weeks on/1 week off schedule) on days 71, 78, 85, 99, 106, and 113.
Procedure: Pancreatic Surgery
Radiation: Radiation therapy
Other Names:Drug: 5-FU
Other Names:Drug: Alpha-interferon Drug: Gemcitabine
Other Name: Gemzar
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00660270
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63119|
|Principal Investigator:||David Linehan, MD||Washington University School of Medicine|