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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: December 2, 2013
Last verified: December 2013

April 29, 2011
December 2, 2013
September 2008
July 2012   (final data collection date for primary outcome measure)
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 PET/CT scan may be used to aid in diagnoses of local tumor recurrence.
Same as current
Complete list of historical versions of study NCT01346410 on ClinicalTrials.gov Archive Site
late toxicity rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Toxicities will be graded using CTCAE criteria at specifiec timepoints.
Same as current
Not Provided
Not Provided
 
Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient age >= 18 years
  • Zubrod 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346410
08-060
No
Bethany Sleckman, St. John's Mercy Research Institute, St. Louis
St. John's Mercy Research Institute, St. Louis
Not Provided
Not Provided
St. John's Mercy Research Institute, St. Louis
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP