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)
This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Primary Objectives Phase II: 1.1.1 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: 1.1.2 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. 1.1.3 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.
Chemotherapy (NOS); Therapy (NOS)
Aloxi (Palonosetron); Aprepitant (); Dexamethasone (); Fosaprepitant (); Granisetron (); KCL (); Mannitol (); MgSO4 (); Olanzapine (); Ondansetron (); Palonosetron (); Zofran (Ondansetron); cisplatin ()
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