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

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IORT
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, IrvineRecruiting
  • Mayo Clinic, JacksonvilleRecruiting
  • Massachusetts General Hospital Cancer CenterRecruiting
  • Mayo Clinic, RochesterRecruiting
  • University of North, Carolina Chapel HillRecruiting
  • Ohio State University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IORT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Adverse events associated with IORT
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

Full Information

First Posted
October 21, 2018
Last Updated
September 7, 2022
Sponsor
Massachusetts General Hospital
Collaborators
IntraOp/Mobetron
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1. Study Identification

Unique Protocol Identification Number
NCT03716531
Brief Title
Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement
Acronym
PACER
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
IntraOp/Mobetron

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IORT
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
IORT
Intervention Description
IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy
Primary Outcome Measure Information:
Title
2 Year Overall Survival
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Median Progression Free Survival
Description
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.
Time Frame
2 years
Title
Local Control
Description
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.
Time Frame
2 years
Title
Adverse events associated with IORT
Description
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theodore S. Hong, MD
Phone
617-724-4000
Email
tshong1@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore S. Hong, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Imagawa, MD, PhD
First Name & Middle Initial & Last Name & Degree
David Imagawa, MD, PhD
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byron May, MD
First Name & Middle Initial & Last Name & Degree
Byron May, MD
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore S. Hong, MD
Phone
617-724-4000
Email
tshong1@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Theodore S. Hong, MD
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Haddock, MD
First Name & Middle Initial & Last Name & Degree
Michael Haddock, MD
Facility Name
University of North, Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wang, MD
First Name & Middle Initial & Last Name & Degree
Andrew Wang, MD
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Miller, MD
First Name & Middle Initial & Last Name & Degree
Eric Miller, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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