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.
Radiation Therapy Oncology Group Study 91-11 offers patients withstage III and IV squamous cell carcinoma of the glottic and supraglotticlarynx a chance to save their voice box.
Standard treatment has, for the most part, been major surgeryfor these patients--major surgery usually to remove the larynx,said Dr. Jim Cox, RTOG chair. All arms of this study provide forlaryngeal preservation, he said.
Patients are randomized to one of three arms. Patients in onearm of the study receive radiation therapy alone to a total doseof 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) administeredon days 1, 22, and 43 of radiation treatments.
The remaining patients receive two cycles of cisplatin (100 mg/m²over 20 to 30 minutes) followed by 5-FU (1 gm/m²/24 hoursover 120 hours). If there is a total or partial response, thepatients undergo another cycle of chemotherapy and begin radiationtherapy.
If there is no response, patients undergo surgery followed byradiation therapy.
The goal of this study is to preserve laryngeal function in thesepatients, said Dr. Cox.
Because of the importance of this trial, facilities are beingreimbursed $1,200 rather than the standard $750 per patient.