Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00233415
First received: October 3, 2005
Last updated: June 1, 2010
Last verified: June 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery [ Time Frame: unknown ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2003
Study Completion Date: May 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Albert Koong, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00233415     History of Changes
Other Study ID Numbers: PANC0001, PANC0001
Study First Received: October 3, 2005
Last Updated: June 1, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014