A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
- Before beginning study treatment, participants will be asked to fill out a Quality of
Life (QOL) questionnaires, a Speech Assessment, a ChemoSensory Questionnaire, a Patient
Swallowing Diary, A Swallowing Study, Salivary Tests and a Trismus Assessment.
Participants will need to go to the Massachusetts Eye and Ear Infirmary (MEEI) or
Massachusetts General Hospital (MGH) for these tests.
- Radiation therapy will be given once a day, five days a week, for seven weeks. This
will be given as outpatient care at the Northeast Proton Therapy Center (proton
component) and Massachusetts General Hospital (photon component).
- During radiation treatments, participants will receive cisplatin intravenously once
every three weeks. This three-week period is called a cycle of treatment.
- After the completion of radiation, participants will receive cisplatin intravenously
once every 4 weeks along with fluorouracil as a continuous infusion over 4 days
starting on the day cisplatin is given, for three cycles.
- Participants will have a physical exam and blood work drawn weekly to monitor their
- An MR/CT scan of the head and neck will be done 2 months after the radiation treatment.
- Follow-up visits will occur once every three months for 2 years, then once every 6
months during years 3-5, then annually. During these follow-up visits, participants
will have the following tests and procedures: physical examination; blood work; chest
CT scan and CT/MRI of the head and neck will be repeated once every 6 months during the
first three years; swallow study; salivary study; QOL questionnaires; speech
assessment; ChemoSensory Questionnaire; and Trismus Assessment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To test the hypothesis that reduction of radiation dose to normal tissue can reduce acute toxicity and increase treatment compliance to combined modality treatment.
Annie W Chan, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|