Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer
Phase 2
Completed
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00233415
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States