A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages

Inclusion Criteria

• •Age greater than or equal to 18 years.
• •Histopathologically confirmed diagnosis of one the following cancer types:
• •* Squamous cell carcinoma
• •* Esthesioneuroblastoma
• •* Adenoid cystic carcinoma
• •* Adenocarcinoma
• •Paranasal sinus/nasal cavity malignancy is considered unresectable with negative margins surgery or resection would be considered excessively morbid. This could include lesions with:
• •* Carotid involvement
• •* Cavernous sinus invasion
• •* Brain invasion
• •* Orbital apex
• •* Intraconal space
• •* Pterygoid musculature involvement
• •* Invasion of the clivus
• •Patients must be a candidate for surgery (as per treating surgeon) and be able to tolerate proton radiation and chemotherapy (as per treating radiation oncologist and medical oncologist).
• •Karnofsky performance statue \>/= 70
• •The subject has organ and marrow function and laboratory values rendering safe administration of Cisplatin:
• •* The ANC \>/= 1000/mm3 without colony stimulating factor support
• •* Platelets \>/= 100,000/mm3
• •* Hemoglobin \>/= 9 g/dL
• •* Bilirubin \</= 1.5 mg/dL the ULM. For subjects with Gilbert's disease, bilirubin \</= 3.0 mg/dL
• •* Serum albumin \>/= 2.8 g/dl
• •* Creatinine clearance (CrCl) \>/= 60 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:
• •* Male: CrCl (mL/min) = (140 = age) x wt (kg) / (serum creatinine x 72)
• •* Female: Multiply above result by 0.85
• •* ALT and AST \</= 3.0 ULN
• •* Serum phosphorus, calcium, magnesium and potassium \>/= LLN
• •No evidence of intercurrent infection
• •Negative pregnancy test for women of childbearing potential (\<51 years of age) as per institutional policy.
• •Patients with distant metastatic disease may not be included.
• •Patient must be able to read and write in English.