Sponsor: NRG
Sponsor Study ID: NRG-HN009
Study Title: Randomized Phase II/III Trial of Radiation with High Dose Cisplatin (100mg/m2) Every Three Weeks Versus Radiation with Low Dose Cisplatin (40mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
CTO #: 103627
NCT Number: NCT05050162
Phase: II/III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Larynx; Lip, Oral Cavity and Pharynx
Study Objectives: This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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.