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Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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