Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Radiation Therapy Oncology Group
With
OBJECTIVES: Primary * Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone. Secondary * Compare progression-free survival of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare quality of life, functional/performance status, and quality-adjusted survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27, 34-41, and 48-55. * Arm II: Patients receive 1 of the following cisplatin-based\* regimens at the discretion of the treating physician: * Regimen 1: Patients receive cisplatin\* IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4. * Regimen 2: Patients receive cisplatin\* IV over 1-2 hours and paclitaxel IV over 3 hours on day 1. * Regimen 3: Patients receive cisplatin\* IV over 1-2 hours and docetaxel IV over 1 hour on day 1. NOTE: \*Carboplatin may be substituted for cisplatin in patients with creatinine clearance \< 50 mL/min or in patients who experience grade 2 or 3 neurotoxicity. For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond documentation of CR. Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study within 5½ years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
