This phase II trial studies how well endoscopic surgery followed by cisplatin and proton beam radiation therapy works in treating patients with nasal tumors that cannot be removed by surgery. Endoscopic surgery is a type of operation that uses small tubes containing a camera and small tools so that a large incision does not need to be made. Proton beam radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Endoscopic surgery followed by cisplatin and proton beam radiation therapy may work better in treating patients with nasal tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03274414.
PRIMARY OBJECTIVE:
I. To determine if near-total resection with minimally invasive endoscopic approach for unresectable paranasal sinus/nasal cavity tumors followed by concurrent chemotherapy and proton-beam radiation improves local control at 1 year after treatment compared to traditional approaches of non-surgical management alone.
SECONDARY OBJECTIVES:
I. To assess the complications of treatment related to minimally invasive endoscopic skull base surgery in patients with unresectable disease using Clavien-Dindo classification of surgical complications.
II. To assess toxicity of treatment based on Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 scores in the acute setting (throughout treatment and up to the 3 month visit after end of treatment).
III. To assess toxicity of treatment based on CTCAE v4.03 scores in the long-term setting (after the 3 month post treatment visit until the 24 month post treatment visit).
IV. To assess toxicity of treatment related to patient reported outcomes including European Organization for Research and Treatment of Cancer (EORTC) (head and neck [H&N] 43 and C30) and Skull Base Inventory (SBI).
V. To determine the 1- and 2-year rates of regional/nodal, or distant-metastasis progression incidence, progression-free survival, disease specific mortality, and overall survival in our group of patients undergoing near-total endoscopic resection (NTR)/proton-beam radiation therapy (PBRT) and chemotherapy.
VI. To obtain tissue of these rare tumor types for IMPACT assessment.
OUTLINE:
Patients undergo endoscopic surgery per standard of care. Beginning 6-8 weeks after surgery, patients undergo PBRT daily (QD). Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1-2, 21-22, and 42-43. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 12, and 24 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMarc Cohen
