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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

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

NCT ID

NCT03716531

First Posted

October 21, 2018

Last Updated

September 7, 2022

Sponsor

Massachusetts General Hospital

Collaborators

IntraOp/Mobetron

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

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

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

Time Frame

2 years

Title

Local Control

Description

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

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

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

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

Learn more about this trial

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

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