Electron Beam Intraoperative Radiation Therapy Following Chemoradiation In Patients With Pancreatic Cancer With Vascular Involvement

Study Overview

Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement

This research study is studying an intervention as a possible treatment for pancreatic cancer.

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.

Pancreas Cancer

RADIATION: IORT

18-267

Study Record Dates

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
First Submitted 2018-10-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-09-07
First Submitted that Met QC Criteria 2018-10-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-09-08
First Posted (ACTUAL) 2018-10-23	Results First Posted N/A	Last Verified 2022-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: IORT * IORT will be administered as determined to be best practice by the treating radiation oncologist, * Electron beam intraoperative radiation therapy will occur in a hybrid operating room with a portable linear accelerator	RADIATION: IORT IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: IORT

* IORT will be administered as determined to be best practice by the treating radiation oncologist, * Electron beam intraoperative radiation therapy will occur in a hybrid operating room with a portable linear accelerator

RADIATION: IORT

IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy

Primary Outcome Measures	Measure Description	Time Frame
2 Year Overall Survival	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.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Median Progression Free Survival	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.	2 years
Local Control	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.	2 years
Adverse events associated with IORT	Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Theodore S. Hong, MD

Phone Number: 617-724-4000

Email: tshong1@mgh.harvard.edu

Participation Criteria

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:

Age ≥ 18 years
ECOG Performance Status 0-1
Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)
Previous completion of either stereotactic-body radiation therapy (SBRT) (minimum 24 Gy) or external beam irradiation (EBRT) (minimum 45 Gy)
Participation in any investigational drug study within 4 weeks preceding the start of study treatment is PERMITTED.
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after IORT.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
Ability to understand and the willingness to sign a written informed consent document

Evidence of disease progression or distant metastases.
Pregnant or lactating women
Treatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
An active infection requiring systemic therapy
Other serious medical conditions that the investigator feels might compromise study participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

IntraOp/Mobetron

Investigators

PRINCIPAL_INVESTIGATOR: Theodore S. Hong, MD, Massachusetts General Hospital

Publications

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

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Resources

Patients

Caregivers

Clinical Trial Record