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A Phase I Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla

Phase 1
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase I Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla

Inclusion Criteria:

- Patients must have histologically confirmed, unresected cancer of the pancreas or
ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma,
neuroendocrine carcinoma).

- Patients must have measurable radiographic disease.Patients with previous complete
resection are only eligible if there is measurable radiographic disease which is
clearly felt to represent locally recurrent disease.

- Patients may receive any number of cycles of chemotherapy prior to treatment with
SBRT, but not within 2 weeks of the first fraction of RT.

- Age > or = 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or
= 60%)

- Life expectancy of greater than 3 months.

- Patients must have normal organ and marrow function.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Concurrent investigational therapy delivered over the period of treatment or
observation (28 days post-RT) for dose limiting toxicity.

- Prior radiation therapy to the abdominal area which would overlap with the proposed
area of treatment.

- Pregnancy.

- Primary disease > 7.5 cm in largest diameter as measured by CT or MRI.

- Gross extension of tumor into the lumen of the duodenum.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy
within 3 months before RT or 6 months after RT.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Stanley Liauw, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

April 2017

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Stereotactic Radiation
  • Pancreatic Neoplasms



University of Chicago Chicago, Illinois  60637