A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy
Subjects will receive daily proton radiation treatment as outpatients at the Francis H. Burr
Proton Center at Massachusetts General Hospital. The subjects may also receive concurrent
standard chemotherapy every week during their radiation therapy. This chemotherapy is
considered standard treatment for their cancer and is not being done for research purposes.
In addition to daily radiation treatments, subjects will have the following tests every
week: review of side effects; physical exam, including weight, height, neurological exam and
vital signs; and blood tests, only for those subjects also receiving chemotherapy.
Subjects will be followed for 5 years after the completion of study treatment. The first
follow-up visit will be 6-8 weeks after completion of study treatment. Additional follow-up
visits will be performed every 3 months during the first 2 years following completion of
radiation then every 6 month during years 3-5. At each follow-up visit, subjects will
receive a physical exam, chest CT scan (at 1st follow-up visit then at least every 6
months), a CT or MRI tumor assessment (at 1st follow-up visit then at least every 6 months),
quality-of-life questionnaire, hearing test, neuro-ophthalmology test, and neurocognitive
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Local Control Rates
To determine the local control rates with IMRT or proton radiation therapy at 2 years.
Annie W Chan, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|