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Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00233415
Enrollment
100
Registered
2005-10-05
Start date
2003-07-31
Completion date
2007-05-31
Last updated
2010-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

DEVICEStereotactic Radiosurgery (Cyberknife)

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026