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Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00233415
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Stanford University

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: Stereotactic Radiosurgery (Cyberknife) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer
Study Start Date : July 2003
Primary Completion Date : March 2006
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Albert Koong, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00233415     History of Changes
Other Study ID Numbers: PANC0001
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases