Clinical Trial Finder

Inclusion Criteria:

• - Biopsy proven, within 16 weeks prior to study entry, sinonasal adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, squamous cell carcinoma, including sinonasal carcinoma, sinonasal undifferentiated carcinoma, Schneiderian carcinoma, myoepithelial carcinoma, undifferentiated carcinoma, esthesioneuroblastoma, or melanoma AJCC 7th edition Stage III - IVA/B tumors, or with skull base or intracranial extension.

Pathology must be confirmed by review at the treating institution.

• - Patients with biopsy proven locally advanced sinus, nasal cavity, hard palate, soft palate, major or minor salivary gland tumors, or lacrimal apparatus, with nasal cavity, sinus, auditory canal, or skull base involvement are eligible.

• - Eastern cooperative oncology group (ECOG) performance status 0 - 1 or Karnofsky Performance Status ≥ 70.

(Appendix B)

• - All patients must undergo pre-treatment evaluation of tumor extent prior to study entry through imaging studies and clinical examinations, including CT and/or MRI of skull base, brain and neck within 28 days prior to study entry; physical examination +/- nasal endoscopy within 28 days prior to study entry; and CT of the chest within 60 days prior to study entry.

• - Nutritional and general physical condition must be considered compatible with the proposed radiation +/- chemotherapy treatment.

• - Normal organ and marrow function.

Exclusion Criteria:

• - Active alcohol addiction.

• - Pregnant or breastfeeding.

• - Receiving any other study agents.

• - History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin for subjects who will receive chemotherapy.

• - Evidence of distant metastases or distant leptomeningeal metastases.

• - Previous irradiation for head and neck tumor, skull base, or brain tumors.

• - Uncontrolled intercurrent illness.

• - History of a different malignancy unless disease-free for at least 2 years and are deemed by the investigator to be at low-risk for recurrence.

Individuals with the following cancers are eligible if diagnosed and treated for cure within the past 2 years: cervical cancer in situ, carcinoma in situ of the breast, and basal cell or squamous ceel carcinoma of the skin

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 test.

Arms

Active Comparator: Proton beam therapy

Subjects treated at Massachusetts General Hospital with proton beam therapy

Active Comparator: IMRT

Intensity-modulated radiation therapy at institutions other than Massachusetts General Hospital

Interventions

Radiation: - Proton radiation therapy

Daily proton radiation therapy

Radiation: - Intensity-modulated radiotherapy

Daily intensity-modulated radiotherapy