A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]
- Compare overall survival of patients with limited stage small cell lung cancer treated
with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily
- Compare local progression-free survival of patients treated with these regimens.
- Compare metastasis-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare response rates in patients treated with these regimens.
- Compare the cytotoxic dose intensity of these regimens in these patients.
- Compare the dose intensity of two different schedules of radiotherapy in these
OUTLINE: This is a multicenter, randomized, controlled study. Patients are stratified
according to participating center, ECOG performance status (0-1 vs 2), and lactic
dehydrogenase, sodium, and alkaline phosphatase levels. Patients are randomized to 1 of 2
- Arm I: Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and
etoposide IV over 45-90 minutes on days 1-3. Treatment repeats every 21 days for up to
6 courses. During course 2, patients undergo concurrent radiotherapy once daily 5 days
a week for 6½ weeks (total of 33 fractions).
- Arm II: Patients receive cisplatin and etoposide as in arm I. During courses 2 and 3,
patients undergo concurrent radiotherapy twice daily 5 days a week for 3 weeks (total
of 30 fractions).
In both arms, treatment continues in the absence of disease progression or unacceptable
Beginning 3-4 weeks after completion of chemoradiotherapy, patients in both arms achieving a
complete or partial response with no evidence of brain metastasis undergo prophylactic
cranial irradiation once daily 5 days a week for 2 weeks (total of 10 fractions).
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 532 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Corinne Faivre-Finn, MD
Christie Hospital NHS Foundation Trust
United Kingdom: Research Ethics Committee