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Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Phase I/II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

Clinical Trial Summary

The purpose of this research study is to determine if it is possible to deliver high dose radiation in one week while also giving the drug capecitabine for the treatment of pancreatic cancer prior to surgery, to determine if this treatment can be given safely for the treatment of pancreatic cancer prior to surgery and, to determine if this treatment can improve the local control pancreatic cancer prior to surgery compared to historical controls of standard treatment.

Clinical Trial Description

OBJECTIVES:

Primary

- Phase I: To determine the feasibility and tolerability of radiation therapy for pancreatic cancer delivered with high dose external beam radiation in a one week accelerated schedule with concurrent capecitabine

- Phase II: To demonstrate a grade 3 or greater (any) toxicity rate of less than 20%

Secondary

- To determine local control and recurrence patterns of pancreatic cancer relative to a standard regimen of 50.4 Gy as seen in historical controls

- To determine the pathologic response rate

- To determine the progression-free survival

- To determine the surgical morbidity

- To determine 30-day post-operative mortality after pancreatic resection ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00889187
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date December 2009
Completion date December 30, 2011
View Details
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