Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Stereotactic Body Radiotherapy

• Registration Number: NCT01346410
• Lead Sponsor: Mercy Research

Brief Summary

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.

Detailed Description

This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.

Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2018-01-24
• Results First Submitted QC: 2018-02-20
• Results First Posted: 2018-02-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patient age >= 18 years
• Performance status of 0-3
• Unresectable pancreatic cancer
• Maximum tumor diameter < 7.5 cm
• Signed study-specific consent form

Exclusion Criteria

• Maximum tumor diameter > 7.5 cm
• Prior radiotherapy to the upper abdomen
• Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
• Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Stereotactic Body Radiotherapy	Stereotactic Radiation to Pancreas

Primary Outcome Measures

Name	Time	Method
Local Control Rate	5 years	Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.

Secondary Outcome Measures

Name	Time	Method
Late Toxicity Rate	5 years	Toxicities will be graded using CTCAE criteria at specified timepoints.

Trial Locations

Locations (1)

St. John's Mercy Medical Center; 🇺🇸 Saint Louis, Missouri, United States