Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement (PACER)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03716531|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Radiation: IORT||Not Applicable|
In this research study, the investigators are researching how well IORT during surgery works in treating pancreatic cancer after 3-6 months of chemotherapy and external radiation therapy. IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy. The investigators believe that the administration of IORT after 3-6 months of chemotherapy will help to stop the cancer cells from growing.
The FDA (the U.S. Food and Drug Administration) has not approved IORT for this specific disease but it has been approved for other uses.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PACER (Pancreatic AdenoCarcinoma With Electron Intraoperative Radiation Therapy): A Phase II Study of Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement|
|Actual Study Start Date :||March 19, 2019|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||November 30, 2023|
IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy
- 2 Year Overall Survival [ Time Frame: 2 years ]Overall survival is defined as the time from IORT to death due to any cause, or is censored at the date of last follow-up, when applicable.
- Median Progression Free Survival [ Time Frame: 2 years ]Progression-free survival is defined as the time from the date of IORT until the first evidence of local progression or distant metastasis (determined by imaging or biopsy) or death, and is censored at date of last follow-up when applicable.
- Local Control [ Time Frame: 2 years ]Local control is the absence of local failure, defined as evidence of growth or regrowth of the primary tumor and/or extension to regional lymph nodes that meets criteria for progressive disease beyond that present in pre-IORT imaging studies.
- Adverse events associated with IORT [ Time Frame: 2 years ]Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716531
|Contact: Theodore S. Hong, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Theodore S. Hong, MD 617-724-4000 firstname.lastname@example.org|
|Principal Investigator: Theodore S. Hong, MD|
|Principal Investigator:||Theodore S. Hong, MD||Massachusetts General Hospital|