A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Jose Belderbos, MD
The Netherlands Cancer Institute
United States: Federal Government