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Randomized Phase II Feasibility Study of Cetuximab Combined With 4 Cycles of TPF Followed by Platinum Based Chemo-radiation Strategies
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. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high energy x- rays to kill tumor cells. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of radiation therapy, combination chemotherapy, and cetuximab and is most effective in treating patients with head and neck cancer. PURPOSE: This randomized phase II trial is comparing two different regimens of radiation therapy given together with combination chemotherapy and cetuximab to see how well they work in treating patients with newly diagnosed stage III or stage IV head and neck cancer that cannot be removed by surgery.
Details
| Lead sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 47 |
| Start date | 2008-02 |
| Completion | 2011-04 |
Conditions
- Head and Neck Cancer
Interventions
- cetuximab
- carboplatin
- cisplatin
- docetaxel
- fluorouracil
- fluorescence in situ hybridization
- molecular genetic technique
- reverse transcriptase-polymerase chain reaction
- immunoenzyme technique
- immunohistochemistry staining method
Primary outcomes
- Feasibility of the chemoradiotherapy part of the treatment, assessed as at least 80% dose intensity of any of the radiotherapy, the platinum, and cetuximab during the chemoradiotherapy part of the treatment
Countries
Belgium