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Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bethany Sleckman, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01346410
First received: April 29, 2011
Last updated: April 14, 2016
Last verified: April 2016
History of Changes
  Purpose
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 Intervention Phase
Pancreatic Cancer
 Radiation: Stereotactic Body Radiotherapy
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • local control rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • late toxicity rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Toxicities will be graded using CTCAE criteria at specified timepoints.
Enrollment: 1
Study Start Date: September 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: April 29, 2011
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016