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Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
This study has been completed.
Sponsor:
St. John's Mercy Research Institute, St. Louis
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
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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: | 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 |
Resource links provided by NLM:
Further study details as provided by Bethany Sleckman, St. John's Mercy Research Institute, St. Louis:
Primary Outcome Measures:
- 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:
- late toxicity rate [ Time Frame: 5 years ]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) |
| 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
Contacts and Locations
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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
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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017