Phase I/II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer
- Since we are looking for the best schedule and dose of radiation that can be
administered safely without severe or unmanageable side effects in participants with
pancreatic cancer, not everyone who participates in this research study will receive
the same dose of radiation therapy. The dose participants will get will depend upon
the number of participants enrolled in the study and how well they have tolerated their
- Radiation treatment days will begin on a weekday and continue for a total of 7 to 12
days. Capecitabine pills will begin on the morning of the first day of radiation and
be taken twice a day for 10 consecutive weekdays, while the participant is receiving
- Blood tests, vital signs and a physical exam will be performed on day 1 and day 15 and
either days 7, 8, or 9.
- Surgery will be performed 1 to 3 weeks after completion of radiation and capecitabine.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To determine the feasibility and tolerability of radiation therapy for pancreatic cancer delivered with high dose external beam radiation in a one week accelerated schedule.
Harvey Mamon, MD, PhD
Brigham and Women's Hospital/Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|