At a glance
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Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
In Brief
A Phase 3 clinical trial evaluating cetuximab, cisplatin, and 1 other intervention for Head and Neck Cancer and Precancerous Condition. Completed, enrolled 987 participants across 185 sites in 2 countries.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. 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. 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. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
Study Details
Timeline
Interventions
400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
100 mg/m2 IV on days 1 and 22 of IMRT
35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.