Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer
- Not everyone who participates in this research study will receive the same schedule of
radiation therapy. The schedule of radiation therapy will depend on the number of
participants enrolled on the study and how well they have tolerated their radiation
schedule. All patients will receive proton beam therapy.
- Here are the proposed schedules of radiation therapy. If at any point too many subjects
experience too many unacceptable side effects, no subject will be enrolled to the next
level. Dose Level 1: 10 radiation sessions given Monday-Friday for two weeks. Dose
Level 2: 5 radiation sessions given Monday, Wednesday and Friday in Week 1 and Tuesday
and Thursday in Week 2. Dose Level 3: 5 radiation sessions given Monday, Tuesday,
Thursday and Friday in Week 1 and Monday in Week 2. Dose Level 4: 5 Radiation sessions
given Monday through Friday in Week 1.
- In Dose Levels 2, 3 and 4, there are fewer radiation sessions, but the radiation dose
given at each session is slightly higher than the dose given in each of the 10 sessions
of Dose Level 1.
- Capecitabine will be given orally (pill form) starting on the first day of radiation
therapy and will be taken for the two weeks that the participant receives radiation
- On days 1, 8 and 15 of each study cycle, the participant will be seen at the clinic
for: physical examination, questions about side effects; and routine blood tests.
- After the last day of study treatment there will be up to a six-week rest period before
surgery is performed.
- About three to six weeks after the participant has finished study treatment, the
following procedures will be done: CT or MRI, physical examination; questions about
side effects and blood tests.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility and tolerability of radiation therapy delivered with proton beam in a one week accelerated schedule with concurrent capecitabine for pancreatic cancer.
Theodore Hong, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|