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Protocol Summary


Protocol No.
PSCI-21-207
Prinicipal Investigator
Mahase, Sean
Phase
Phase II/III
Age Group
Adult
Scope
National
Secondary Protocol No.
NRG HN009
Title
NRG HN009- Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks Versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Objective
Phase II: To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN).

Phase III: To determine whether radiation with low-dose cisplatin weekly is non-inferior to radiation with high-dose cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN. To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced SCCHN.

Secondary Objectives
To assess and compare progression-free survival (PFS) between arms.
To assess and compare locoregional failure and distant metastasis between arms.
To assess acute and late toxicity (CTCAE v5.0).
To assess patient-reported outcomes quality of life (PRO/QOL), as measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (primary PRO), between arms.
To assess hearing loss, as measured by audiograms and the modified TUNE grading scale between arms.
To assess hearing loss, as measured by speech audiometry Consonant-Nucleus-Consonant word scores and tympanometry (subject to the modified TUNE grading scale testing results; otherwise, it will be an exploratory objective).
To assess hearing-related QOL as measured by the Hearing Handicap Inventory-Screening (HHIA-S) (secondary PRO), between arms.
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center