At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of the head and neck from oral cavity, oropharynx, larynx, or hypopharynx
- ✓AJCC pathological stage III or IV
- ✓Gross total resection completed within 7 weeks of randomization with high-risk pathologic features (extracapsular nodal extension, ≥2 involved regional lymph nodes, or invasive cancer at resection margin)
- ✓No evidence of distant metastases
- ✕Prior head and neck radiotherapy
- ✕Prior anti-EGFR antibody therapy
- ✕Prior cytotoxic chemotherapy within 3 years
- ✕Prior tyrosine kinase inhibitor therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck
In Brief
A Phase 2 clinical trial evaluating cetuximab, cisplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 238 participants across 160 sites.
Detailed Summary
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
Study Details
Timeline
Interventions
400 mg/m\^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m\^2 intravenously over 60 minutes in weeks 2 through 7.
30 mg/m\^2 intravenously infused over over 60 minutes in weeks 2 through 7.
15 mg/m\^2 intravenously infused over 30 minutes in weeks 2 through 7.
60 Gy (2 Gy once a day, 5 times a week)