CLASSIC
Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial
Phase 3N = 1,035NCT00411229
- Population
- Patients with stage II-IIIB gastric cancer after curative D2 gastrectomy (South Korea, China, Taiwan).
- Design
- Open-label, parallel-group phase 3 trial in 37 centres in South Korea, China and Taiwan (35 centres in the 5-year report): adjuvant capecitabine (1000 mg/m2 twice daily, days 1 to 14) plus oxaliplatin (130 mg/m2 day 1), eight 3-week cycles, or observation after curative D2 gastrectomy for stage II-IIIB gastric cancer. Block randomisation stratified by country and stage. Primary endpoint 3-year disease-free survival, analysed by intention to treat; the 2012 report is a prespecified interim efficacy analysis after which the trial was stopped, and the 2014 report is the final preplanned 5-year assessment. ClinicalTrials.gov enrolment 1035 matches the papers.
- Primary endpoint
- DFS
- Arms
- Surgery only (observation) (control, n = 515): D2 gastrectomy followed by observation
- Surgery plus adjuvant capecitabine and oxaliplatin (experimental, n = 520): Eight 3-week cycles of capecitabine plus oxaliplatin
- People
- Bang YJ, senior author CLASSIC trial investigators
DFSHR 0.56 (95% CI 0.44–0.72)Δ 36-month DFS+15 pointsDFSHR 0.58 (95% CI 0.47–0.72)Δ 60-month DFS+15 pointsOSHR 0.66 (95% CI 0.51–0.85)Δ 60-month OS+9 points
Show the numbers
| Endpoint | Analysis | Surgery plus adjuvant capecitabine and oxaliplatin | Surgery only (observation) | Effect |
|---|---|---|---|---|
| DFS | interimmedian follow-up 34.2 monthsBang 2012 | 74% at 3 y (69–79%) | 59% at 3 y (53–64%) | HR 0.56 (95% CI 0.44–0.72)P<0.0001Median follow-up was 34.2 months in the chemotherapy group and 34.3 months in the surgery-only group. |
| DFS | finalmedian follow-up 62.4 monthsNoh 2014 | 68% at 5 y (63–73%) | 53% at 5 y (47–58%) | HR 0.58 (95% CI 0.47–0.72)P<0.0001 |
| OS | finalmedian follow-up 62.4 monthsNoh 2014 | 78% at 5 y (74–82%) | 69% at 5 y (64–73%) | HR 0.66 (95% CI 0.51–0.85)P=0.0015 |
| Endpoint | Analysis | Surgery plus adjuvant capecitabine and oxaliplatin | Surgery only (observation) | Effect |
|---|---|---|---|---|
| DFS | interimmedian follow-up 34.2 monthsBang 2012 | 74% at 3 y (69–79%) | 59% at 3 y (53–64%) | HR 0.56 (95% CI 0.44–0.72)P<0.0001Median follow-up was 34.2 months in the chemotherapy group and 34.3 months in the surgery-only group. |
| DFS | finalmedian follow-up 62.4 monthsNoh 2014 | 68% at 5 y (63–73%) | 53% at 5 y (47–58%) | HR 0.58 (95% CI 0.47–0.72)P<0.0001 |
| OS | finalmedian follow-up 62.4 monthsNoh 2014 | 78% at 5 y (74–82%) | 69% at 5 y (64–73%) | HR 0.66 (95% CI 0.51–0.85)P=0.0015 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.56 | 0.44–0.72 |
| DFS | 0.58 | 0.47–0.72 |
| OS | 0.66 | 0.51–0.85 |
Appears in
Sources
Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, et al. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012;379(9813):315-21.
Noh SH, Park SR, Yang HK, Chung HC, Chung IJ, Kim SW, et al. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(12):1389-96.