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2008-09
2012-07
2012-07
1
NCT01346410
Mercy Research
Mercy Research
INTERVENTIONAL
Stereotactic Body Radiotherapy for 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-04-29 | 2018-01-24 | 2020-02-18 |
2011-04-29 | 2018-02-20 | 2020-02-19 |
2011-05-03 | 2018-02-22 | 2020-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: A Stereotactic Radiation to Pancreas | RADIATION: Stereotactic Body Radiotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Local Control Rate | 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. | 5 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Late Toxicity Rate | Toxicities will be graded using CTCAE criteria at specified timepoints. | 5 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
