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
European Organisation for Research and Treatment of Cancer - EORTC
OBJECTIVES: * Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin. * Compare the acute and late toxic effects of these regimens in these patients. * Determine the quality of life of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy. * Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy. Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35. Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
