Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer
18 Years
90 Years
Both
Pancreatic Cancer
Trial Information
Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer
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.
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.
Exclusion Criteria:Chemotherapy within 1 month of registration.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery
Outcome Time Frame:
unknown
Safety Issue:
No
Principal Investigator
Albert Koong
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Institutional Review Board
Study ID:
PANC0001
NCT ID:
NCT00233415
Start Date:
July 2003
Completion Date:
May 2007
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Stanford University School of Medicine | Stanford, California 94305-5317 |
