Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer

Stanford University1 site in 1 country100 target enrollmentJuly 2003

ConditionsPancreatic Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: Stanford University
Enrollment: 100
Locations: 1
Primary Endpoint: Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

Detailed Description

The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

May 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Eligibility Criteria

Inclusion Criteria

•Pancreatic tumors not to exceed 7.5 cm.
•Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met).
•Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA).
•Patients with metastatic disease may be treated if they are symptomatic from the primary tumor.
•Eastern Clinical Oncology Group performance status 0, 1 or 2.