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


Phase 2
18 Years
90 Years
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Albert Koong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PANC0001

NCT ID:

NCT00233415

Start Date:

July 2003

Completion Date:

May 2007

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317