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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pancreas Cancer
• Intervention / Treatment: Radiation: IORT

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Theodore S. Hong, MD; Phone Number: 617-724-4000; Email: tshong1@mgh.harvard.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • University of California, Irvine
      • Contact: David Imagawa, MD, PhD
      • Principal Investigator: David Imagawa, MD, PhD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic, Jacksonville
      • Contact: Byron May, MD
      • Principal Investigator: Byron May, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Theodore S. Hong, MD; Phone Number: 617-724-4000; Email: tshong1@mgh.harvard.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic, Rochester
      • Contact: Michael Haddock, MD
      • Principal Investigator: Michael Haddock, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North, Carolina Chapel Hill
      • Contact: Andrew Wang, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Medical Center
      • Contact: Eric Miller, MD
      • Principal Investigator: Eric Miller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: IntraOp/Mobetron

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2019
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: October 21, 2018
• First Submitted That Met QC Criteria: October 21, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pancreatic Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 18-267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes