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Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01346410
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bethany Sleckman, St. John's Mercy Research Institute, St. Louis

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Stereotactic Body Radiotherapy Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
Study Start Date : September 2008
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Stereotactic Radiation to Pancreas
Radiation: 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)



Primary Outcome Measures :
  1. local control rate [ Time Frame: 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 :
  1. late toxicity rate [ Time Frame: 5 years ]
    Toxicities will be graded using CTCAE criteria at specified timepoints.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346410


Locations
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis

Responsible Party: Bethany Sleckman, Director Oncology Research, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01346410     History of Changes
Other Study ID Numbers: 08-060
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by Bethany Sleckman, St. John's Mercy Research Institute, St. Louis:
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases