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

• ClinicalTrials.gov Identifier: NCT03716531
• Recruitment Status: Recruiting
• First Posted: October 23, 2018
• Last Update Posted: March 28, 2019
• Sponsor: Massachusetts General Hospital
• Collaborator: IntraOp/Mobetron
• Information provided by (Responsible Party): Theodore Sunki Hong, Massachusetts General Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pancreas Cancer	Radiation: IORT	Not Applicable

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. Adverse events associated with IORT [ Time Frame: 2 years ]
   Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Theodore S. Hong, MD; 617-724-4000; tshong1@mgh.harvard.edu

Locations

United States, Massachusetts

Massachusetts General Hospital Cancer Center; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Theodore S. Hong, MD 617-724-4000 tshong1@mgh.harvard.edu

Principal Investigator: Theodore S. Hong, MD

Sponsors and Collaborators

Massachusetts General Hospital

IntraOp/Mobetron

Investigators

• Principal Investigator: Theodore S. Hong, MD; Massachusetts General Hospital

More Information

• Responsible Party: Theodore Sunki Hong, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03716531
• Other Study ID Numbers: 18-267
• First Posted: October 23, 2018
• Last Update Posted: March 28, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:

Pancreatic Cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases