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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) (PSCI# 21-207) (NRG-HN009)
The purpose of this study is to compare two usual treatment approaches to your head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.
he first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks.The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach.There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.
Age ≥ 18
Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration
Adequate hematologic function within 30 days prior to registration
Adequate renal function within 30 days prior to registration defined as calculated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula
Definitive clinical or radiologic evidence of distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnancy and individuals unwilling to discontinue nursing