Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01346410 |
Recruitment Status :
Completed
First Posted : May 3, 2011
Results First Posted : February 22, 2018
Last Update Posted : February 19, 2020
|
Sponsor:
Mercy Research
Information provided by (Responsible Party):
Kathy Baglan, MD, Mercy Research
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | April 29, 2011 | ||
First Posted Date ICMJE | May 3, 2011 | ||
Results First Submitted Date ICMJE | January 24, 2018 | ||
Results First Posted Date ICMJE | February 22, 2018 | ||
Last Update Posted Date | February 19, 2020 | ||
Study Start Date ICMJE | September 2008 | ||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
|
||
Original Primary Outcome Measures ICMJE |
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 PET/CT scan may be used to aid in diagnoses of local tumor recurrence.
|
||
Change History | |||
Current Secondary Outcome Measures ICMJE |
Late Toxicity Rate [ Time Frame: 5 years ] Toxicities will be graded using CTCAE criteria at specified timepoints.
|
||
Original Secondary Outcome Measures ICMJE |
Late Toxicity Rate [ Time Frame: 5 years ] Toxicities will be graded using CTCAE criteria at specifiec timepoints.
|
||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer | ||
Official Title ICMJE | Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer | ||
Brief Summary | 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. | ||
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. |
||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | Pancreatic Cancer | ||
Intervention ICMJE | 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)
|
||
Study Arms ICMJE | Experimental: A
Stereotactic Radiation to Pancreas
Intervention: Radiation: Stereotactic Body Radiotherapy
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
1 | ||
Original Estimated Enrollment ICMJE |
20 | ||
Actual Study Completion Date ICMJE | July 2012 | ||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01346410 | ||
Other Study ID Numbers ICMJE | 08-060 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Kathy Baglan, MD, Mercy Research | ||
Study Sponsor ICMJE | Mercy Research | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Mercy Research | ||
Verification Date | February 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |