Clinical trial NCT03716531: Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement
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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Keywords: Pancreatic Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: IntraOp/Mobetron
First posted: 2018-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 2 Year Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: Median Progression Free Survival
timeFrame: 2 years
measure: Local Control
timeFrame: 2 years
measure: Adverse events associated with IORT
timeFrame: 2 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North, Carolina Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Massachusetts General Hospital
name: Theodore S. Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: