Sodium Thiosulfate for the Prevention of Ototoxicity in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck Undergoing Chemoradiation With Cisplatin

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PRIMARY OBJECTIVE: I. To establish feasibility of intravenous sodium thiosulfate (STS) after each dose of concurrent cisplatin in patients with locally advanced head and neck squamous cell carcinoma undergoing definitive radiotherapy. SECONDARY OBJECTIVES: I. To determine the rate of grade >= 2 chan...

PRIMARY OBJECTIVE: I. To establish feasibility of intravenous sodium thiosulfate (STS) after each dose of concurrent cisplatin in patients with locally advanced head and neck squamous cell carcinoma undergoing definitive radiotherapy. SECONDARY OBJECTIVES: I. To determine the rate of grade >= 2 change from baseline based on Common Terminology Criteria for Adverse Events (CTCAE) version 5 with use of STS after concurrent chemoradiation with cisplatin 3 months post-treatment. II. To determine the rate of tinnitus measured by Patient Reported Outcomes (PRO)-CTCAE with use of STS 3 months post-treatment. III. To describe patient reported outcomes with STS measured with PRO-CTCAE for selected oral, gastrointestinal (GI), neurologic and perceptual symptoms. IV. To describe patient reported outcomes measured with Hearing Handicap Inventory for Adults - Screening (HHIA-S) compared to results from standard NRG Oncology head and neck trials (such as Radiation Therapy Oncology Group (RTOG) 1016). OUTLINE: Patients are assigned to 1 of 2 groups per treating physician's discretion. COHORT A: Patients undergo standard of care radiation therapy daily for 6-7 weeks. Patients receive cisplatin intravenously (IV) on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate IV over 1-2 hours on day 1. Treatment repeats every 7 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity. COHORT B: Patients undergo standard of care radiation therapy daily for 6-7 weeks. Patients receive high-dose cisplatin IV on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 3 years.

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