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
(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
If there is no response, patients undergo surgery followed by
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.