Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Pancreatic Cancer	Device: Stereotactic Radiosurgery (Cyberknife)	Phase II

MedlinePlus related topics:

Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Stanford University:

Primary Outcome Measures:

Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery

Estimated Enrollment:	100
Study Start Date:	July 2003
Estimated Study Completion Date:	May 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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. Exclusion Criteria:Chemotherapy within 1 month of registration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233415

Locations


United States, California
	Stanford University School of Medicine
	Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Albert Koong	Stanford University

More Information

Study ID Numbers:	PANC0001, NCT00233415, PANC0001
First Received:	October 3, 2005
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00233415
Health Authority:	USA:Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Pancreatic Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00233415