Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement (PACER)
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ClinicalTrials.gov Identifier: NCT03716531 |
Recruitment Status :
Recruiting
First Posted : October 23, 2018
Last Update Posted : January 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreas Cancer | Radiation: IORT | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: IORT
|
Radiation: IORT
IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy |
- 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.
- 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.
- 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.
- Adverse events associated with IORT [ Time Frame: 2 years ]Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716531
Contact: Theodore S. Hong, MD | 617-724-4000 | tshong1@mgh.harvard.edu |
United States, California | |
University of California, Irvine | Recruiting |
Irvine, California, United States, 92697 | |
Contact: David Imagawa, MD, PhD | |
Principal Investigator: David Imagawa, MD, PhD | |
United States, Florida | |
Mayo Clinic, Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Byron May, MD | |
Principal Investigator: Byron May, MD | |
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 | |
United States, Minnesota | |
Mayo Clinic, Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Michael Haddock, MD | |
Principal Investigator: Michael Haddock, MD | |
United States, North Carolina | |
University of North, Carolina Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27514 | |
Contact: Andrew Wang, MD | |
Principal Investigator: Andrew Wang, MD | |
United States, Ohio | |
Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Eric Miller, MD | |
Principal Investigator: Eric Miller, MD |
Principal Investigator: | Theodore S. Hong, MD | Massachusetts General Hospital |
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 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | January 2021 |
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 |
Pancreatic Cancer |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |