Clinical Trial - NCT03716531

       

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

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: IntraOp/Mobetron

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Theodore Sunki Hong Principal Investigator

ClinicalTrials.gov Identifier: NCT03716531

Protocol Info

Short Description: Electron Beam Intraoperative Radiation in Panc Cancer
Long Description: 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
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


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Purpose

This research study is studying an intervention as a possible treatment for pancreatic cancer.
Condition Title Intervention Phase
Pancreas Cancer IORT N/A
Study Type Interventional
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

Primary Outcome Measures

2 Year Overall Survival [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Median Progression Free Survival [Time Frame: 2 years] [Designated as safety issue: ]

Local Control [Time Frame: 2 years] [Designated as safety issue: ]

Adverse events associated with IORT [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 200
Study Start Date: March 2019
Estimated Study Completion Date: November 2023
Estimated Primary Completion Date: November 2023
Arms Assigned Interventions

Experimental: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
Radiation:IORT
IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03716531

Locations

  • United States, California
    • University of California, Irvine Irvine, California, United States, 92697
  • United States, Florida
    • Mayo Clinic, Jacksonville Jacksonville, Florida, United States, 32224
  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02215
  • United States, Minnesota
    • Mayo Clinic, Rochester Rochester, Minnesota, United States, 55905
  • United States, North Carolina
    • University of North, Carolina Chapel Hill Chapel Hill, North Carolina, United States, 27514
  • United States, Ohio
    • Ohio State University Medical Center Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Massachusetts General Hospital

IntraOp/Mobetron

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Theodore Sunki Hong Principal Investigator
ClinicalTrials.gov Identifier: NCT03716531
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Pancreatic Cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on January 20, 2021