| Title: |
Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. |
| Authors: |
Faivre-Finn, C; Snee, M; Ashcroft, L; Appel, W; Barlesi, F; Bhatnagar, A; Bezjak, A; Cardenal, F; Fournel, P; Harden, S; Le Pechoux, C; McMenemin, R; Mohammed, N; O'Brien, M; Pantarotto, J; Surmont, V; Van Meerbeeck, JP; Woll, PJ; Lorigan, P; Blackhall, F; CONVERT Study Team |
| Contributors: |
O'Brien, Mary; Marsden |
| Publication Year: |
2018 |
| Collection: |
The Institute of Cancer Research (ICR): Publications Repository |
| Subject Terms: |
CONVERT Study Team; Humans; Lung Neoplasms; Esophagitis; Radiation Pneumonitis; Neutropenia; Cisplatin; Etoposide; Antineoplastic Combined Chemotherapy Protocols; Neoplasm Staging; Survival Rate; Follow-Up Studies; Adult; Aged; 80 and over; Middle Aged; Female; Male; Small Cell Lung Carcinoma; Intention to Treat Analysis; Chemoradiotherapy; Dose Fractionation; Radiation |
| Description: |
Background Concurrent chemoradiotherapy is the standard of care in limited-stage small-cell lung cancer, but the optimal radiotherapy schedule and dose remains controversial. The aim of this study was to establish a standard chemoradiotherapy treatment regimen in limited-stage small-cell lung cancer.Methods The CONVERT trial was an open-label, phase 3, randomised superiority trial. We enrolled adult patients (aged ≥18 years) who had cytologically or histologically confirmed limited-stage small-cell lung cancer, Eastern Cooperative Oncology Group performance status of 0-2, and adequate pulmonary function. Patients were recruited from 73 centres in eight countries. Patients were randomly assigned to receive either 45 Gy radiotherapy in 30 twice-daily fractions of 1·5 Gy over 19 days, or 66 Gy in 33 once-daily fractions of 2 Gy over 45 days, starting on day 22 after commencing cisplatin-etoposide chemotherapy (given as four to six cycles every 3 weeks in both groups). The allocation method used was minimisation with a random element, stratified by institution, planned number of chemotherapy cycles, and performance status. Treatment group assignments were not masked. The primary endpoint was overall survival, defined as time from randomisation until death from any cause, analysed by modified intention-to-treat. A 12% higher overall survival at 2 years in the once-daily group versus the twice-daily group was considered to be clinically significant to show superiority of the once-daily regimen. The study is registered with ClinicalTrials.gov (NCT00433563) and is currently in follow-up.Findings Between April 7, 2008, and Nov 29, 2013, 547 patients were enrolled and randomly assigned to receive twice-daily concurrent chemoradiotherapy (274 patients) or once-daily concurrent chemoradiotherapy (273 patients). Four patients (one in the twice-daily group and three in the once-daily group) did not return their case report forms and were lost to follow-up; these patients were not included in our analyses. At a median ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
Print-Electronic; 1125; application/pdf |
| Language: |
English |
| ISSN: |
1474-5488; 1470-2045 |
| Relation: |
The Lancet. Oncology, 2017, 18 (8), pp. 1116 - 1125; https://repository.icr.ac.uk/handle/internal/1177 |
| Availability: |
https://repository.icr.ac.uk/handle/internal/1177 |
| Rights: |
https://creativecommons.org/licenses/by/4.0 |
| Accession Number: |
edsbas.204329B4 |
| Database: |
BASE |