Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

NCT ID: NCT01346410

Last Updated: 2020-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Stereotactic Radiation to Pancreas

Group Type EXPERIMENTAL

Stereotactic Body Radiotherapy

Intervention Type RADIATION

Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)

Interventions

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Stereotactic Body Radiotherapy

Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mercy Research

OTHER

Sponsor Role lead

Responsible Party

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Kathy Baglan, MD

Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. John's Mercy Medical Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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08-060

Identifier Type: -

Identifier Source: org_study_id

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