This phase II trial studies how well giving intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy (PBRT) together with or without cisplatin works in treating patients with stage III-IVB paranasal sinus and nasal cavity cancer. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more 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. Giving IMRT or PBRT together with cisplatin may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01586767.
PRIMARY OBJECTIVE:
I. To determine the local control rates with IMRT or proton radiation therapy at 2 years.
SECONDARY OBJECTIVES:
I. To determine the acute toxicities of IMRT and proton beam.
II. To determine the regional control, distant metastasis, disease-free survival, and overall survival rates at 2 years.
III. To determine the long-term efficacy results at 5 years.
IV. To determine the late toxicities.
V. To assess quality-of-life (QOL) outcomes.
VI. To determine the patterns of tumor relapse.
VII. To determine the feasibility of conducting a multi-institutional prospective clinical trial in patients with advanced sinonasal malignancy.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
GROUP I: Patients undergo IMRT. Patients with high-risk tumor receive cisplatin intravenously (IV) on days 1, 8, 15, 22, 29, 36, and 43 of radiation therapy.
GROUP II: Patients undergo PBRT. Patients with high-risk tumor receive cisplatin IV on days 1, 8, 15, 22, 29, 36, and 43 of radiation therapy.
In both groups, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months, every 3-6 months for 1 year, and then every 6 months for 4 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAnnie Waifong Chan