NCTN: Radiation Therapy and Cisplatin with or without Cetuximab in Treating Patients with Stage III or Stage IV Head and Neck Cancer (RTOG-0522)
Study ID: RTOG-0522
NCT Number: NCT00265941
NRG Oncology
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin vs Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas (RTOG-0522)
Trial Description: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.
Clinical data presented in the following publication(s):
- PMID 25154822
Disease type(s): Head and Neck Neoplasm - Squamous Cell Carcinoma
Clinical Dataset(s) included:
- NCT00265941-D1 (PMID 25154822): There are two datasets for RTOG-0522's primary publication 25154822 (-D1 and -D2). This dataset, NCT00265941-D1, contains reasons for exclusion, treatment received, treatment discontinuation reasons, baseline characteristics, p16 status, EGFR expression, survival, distant metastases, and use of feeding tube data.
- NCT00265941-D2 (PMID 25154822): There are two datasets for RTOG-0522's primary publication 25154822 (-D1 and -D2). This dataset, NCT00265941-D2, contains adverse event data. This dataset is limited to grade 1-4 adverse events that were attributed as definitely, probably, or possibly related to protocol treatment and occurred in at least 10% of patients in either arm. The acute and late periods are defined as 90 days or fewer and > 90 days, respectively, from the start of radiation therapy.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)