Pancreas CancerPACERNCT03716531
Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement
A study testing IORT in people with Pancreas Cancer, run by Massachusetts General Hospital at 6 sites in United States.
Trial summary
This research study is studying an intervention as a possible treatment for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- IORT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Mar 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North, Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
Ohio State University Medical Center
Columbus, Ohio, 43210
University of California, Irvine
Irvine, California, 92697
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
About this study
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
This research study is studying an intervention as a possible treatment for pancreatic cancer.
Read the 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.
- Conditions
- Pancreas Cancer
- Being tested
- IORT
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IORTRadiation
IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| IORT | Experimental | * 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 Receives: Radiation: IORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 2 years
Adverse events associated with IORT
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start19 Mar 2019
- Primary completion26 Aug 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IntraOp/Mobetron
- Responsible party
- Principal investigator, Jennifer Wo, Massachusetts General Hospital
- Investigators
- Jennifer Wo, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716531
- Sponsor's protocol ID
- 18-267
- Acronym
- PACER
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2018
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03716531
- Acronym / sponsor ID
- PACER / 18-267
- Conditions
- Pancreas Cancer
- Keywords
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- IntraOp/Mobetron
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IORT | Experimental | Radiation: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IORTIORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy | Radiation | IORT |
Primary outcome
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.
3 secondary outcomes
Median Progression Free Survival
Time frame: 2 years
Local Control
Time frame: 2 years
Adverse events associated with IORT
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Wo, MD principal investigator
Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IORT in people with Pancreas Cancer, run by Massachusetts General Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Year Overall Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.