Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT01346410|
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Stereotactic Body Radiotherapy||Phase 4|
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)|
|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|
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)
- 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.
- late toxicity rate [ Time Frame: 5 years ]Toxicities will be graded using CTCAE criteria at specified timepoints.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346410
|United States, Missouri|
|St. John's Mercy Medical Center|
|St. Louis, Missouri, United States, 63141|