RTOG 91-11, a National Cancer Institute high priority laryngeal preservation protocol, has been streamlined and the accrual rate has increased. More than 175 patients have now been accrued to the study.
Patients with T4 disease because of questionable cartilage invasion and patients who have tumors extending up to 1 cm into the base of the tongue are now eligible to participate in the study, said Dr. Arlene Forastiere, a study chair.
The time between initial endoscopy and registration onto the trial has been lengthened to four weeks (rather than three), said Dr. Forastiere.
In addition, a number of followup radiologic studies and blood work have been removed from the protocol, she said. "In this age of cost consciousness, we have limited the followup studies to only those which are absolutely necessary," she said.
The treatment schedule of the protocol is unchanged. Patients are randomized into one of three arms. Patients in Arm One of the study are treated with cisplatin(Drug information on cisplatin) (100 mg/m²) and 5-FU (1 gm/m²/24 hours over 120 hours).
The chemotherapy is given two times, three weeks apart. If there is no response to the chemotherapy, then patients undergo surgery followed 2 to 3 weeks later by radiation therapy (2.0 Gy for 5 days a week for seven weeks). If there is a complete or partial response, an additional cycle of cisplatin and 5-FU is given, followed by radiation therapy.
Patients in Arm Two of the study undergo radiation therapy and concurrent cisplatin (100 mg/m²) every three weeks for a total of three doses.
Patients in Arm Three of the study are treated with radiation therapy alone.
The primary endpoint of the trial is survival; time to recurrence, side effects and quality of life also will be analyzed. RTOG 91-11 is an intergroup study with Eastern Cancer Oncology Group and Southwest Oncology Group participating.