Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT00833261
Brief Summary:
RATIONALE: 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. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Detailed Description:
OBJECTIVES:
Primary
* To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
* To determine the progression-free survival and local-regional progression in these patients.
* To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
* To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
Study:
NCT00833261
Study Brief:
Protocol Section:
NCT00833261