Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally,
daily until the day before surgery and will resume after surgery until study end.
Capecitabine will be taken orally, daily. Proton radiation treatment will start on Week 2
and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation
treatment will be give on an outpatient basis at the Francis H. Burr Proton Center at
Massachusetts General Hospital.
The following tests will be performed weekly: physical exam, routine blood tests, optional
blood tests and an eye exam every 3 months while taking hydroxychloroquine.
Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking
hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include:
physical exam, routine blood tests, eye exam, and tumor assessment by chest and
abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, proton-based chemoradiation therapy and adjuvant gemcitabine chemotherapy
Theodore S Hong, MD
Massachusetts General Hospital
United States: Institutional Review Board
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