Radiation Therapy Oncology Group Study 91-11 offers patients with stage III and IV squamous cell carcinoma of the glottic and supraglottic larynx a chance to save their voice box.
Standard treatment has, for the most part, been major surgery for these patients--major surgery usually to remove the larynx, said Dr. Jim Cox, RTOG chair. All arms of this study provide for laryngeal preservation, he said.
Patients are randomized to one of three arms. Patients in one arm of the study receive radiation therapy alone to a total dose of 70 Gy. Radiation treatments are given 5 days a week for 7 weeks.
Patients in the second arm of the study also receive cisplatin(Drug information on cisplatin) (Platinol--100 mg/m² over 20 to 30 minutes) administered on days 1, 22, and 43 of radiation treatments.
The remaining patients receive two cycles of cisplatin (100 mg/m² over 20 to 30 minutes) followed by 5-FU (1 gm/m²/24 hours over 120 hours). If there is a total or partial response, the patients undergo another cycle of chemotherapy and begin radiation therapy.
If there is no response, patients undergo surgery followed by radiation therapy.
The goal of this study is to preserve laryngeal function in these patients, said Dr. Cox.
Because of the importance of this trial, facilities are being reimbursed $1,200 rather than the standard $750 per patient.