Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01342354|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2011
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Stereotactic Radiation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla|
|Actual Study Start Date :||April 14, 2009|
|Actual Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Stereotactic Radiation
Escalating doses of SBRT in three doses over ten days.
Radiation: Stereotactic Radiation
Escalating Doses of SBRT in periods of three doses over 10 days
- Maximum Tolerated Dose (phase 1) [ Time Frame: 28 days ]Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
- Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas [ Time Frame: 28 days ]
- Reported side effects [ Time Frame: 12 months after treatment ]
- Change in patient reported pain score using visual analog scale [ Time Frame: 12 months after treatment ]Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity.
- Number of patients eligible for surgery to remove tumor after treatment [ Time Frame: 12 months after treatment ]
- Number of patients with disease control [ Time Frame: 12 months after treatment ]Number of patients with no disease progression as measured by tumor imaging
- Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire. [ Time Frame: 12 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342354
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Stanley Liauw, MD||University of Chicago|