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

University of Chicago1 site in 1 country15 target enrollmentApril 14, 2009

ConditionsPancreatic Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: University of Chicago
Enrollment: 15
Locations: 1
Primary Endpoint: Maximum Tolerated Dose (Phase 1)
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.

Registry

clinicaltrials.gov

Start Date

April 14, 2009

End Date

June 1, 2022

Last Updated

9 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

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 document.

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.

Outcomes

Primary Outcomes

Maximum Tolerated Dose (Phase 1)

Time Frame: 28 days

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

Secondary Outcomes

The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity(12 months after treatment)
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale(12 months after treatment)
Number of Patients Eligible for Surgery to Remove Tumor After Treatment(12 months after treatment)
Number of Patients With Local Disease Control(12 months after treatment)
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.(12 months after treatment)