Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

Stanford University

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Device: Stereotactic Radiosurgery (Cyberknife)

Study type: Interventional

Funder types: Other

Identifiers

NCT00233415

NCT00233415

PANC0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)