Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233415
• Other study ID #: PANC0001
• Secondary ID: PANC0001
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: June 1, 2010
• Start date: July 2003
• Est. completion date: May 2007

Study information

• Verified date: June 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Stereotactic Radiosurgery (Cyberknife)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery		unknown	No