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Gastric Cancer · Medical · Adjuvant / Postoperative

CLASSIC

After curative D2 gastrectomy for stage II–IIIB gastric cancer, does adjuvant capecitabine–oxaliplatin improve outcomes versus surgery alone?

Trial design and population

Population / eligibility
1,035 patients with stage II–IIIB gastric cancer after curative D2 gastrectomy in South Korea, China and Taiwan.
Intervention vs comparator
Eight 3-week cycles of capecitabine plus oxaliplatin vs observation after surgery.
Sample size
1,035
Primary endpoint
Disease-free survival

Key results

At 5 years, DFS was 68% with adjuvant CAPOX vs 53% with surgery alone (HR 0.58, 95% CI 0.47–0.72). Five-year OS was approximately 78% vs 69% (HR 0.66, 95% CI 0.51–0.85).

Source-reported outcome visualization

5-year disease-free survival · 5 years

CAPOX
68 %
Observation
53 %

Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.

Absolute Effect

Absolute 5-year DFS gain 15 percentage points; NNT 7 based on 5-year DFS. Approximate 5-year OS gain 9 points; NNT 12 based on 5-year OS.

NNT: 7 (5-year DFS); ≈12 (5-year OS). Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.

NNH: Not quantifiable. Grade 3–4 adverse events occurred in approximately 56% with CAPOX. Hand-foot syndrome, nausea, neutropenia and oxaliplatin neuropathy are important; NNH not calculated without a comparator-matched fixed-time harm endpoint.

Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.

Safety and treatment burden

Grade 3–4 adverse events occurred in approximately 56% with CAPOX. Hand-foot syndrome, nausea, neutropenia and oxaliplatin neuropathy are important; NNH not calculated without a comparator-matched fixed-time harm endpoint.

Follow-up, maturity and limitations

Follow-up: Five-year follow-up analysis.

Conducted in East Asian centres with D2 surgery; does not directly compare postoperative CAPOX with perioperative chemotherapy used in many Western settings.

Clinical interpretation

Adjuvant CAPOX after D2 gastrectomy improves 5-year DFS and OS over surgery alone in resected stage II–IIIB gastric cancer.

Current-practice context · reviewed 20 October 2026

This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.

Primary and authoritative sources

Noh SH, et al. Adjuvant Capecitabine Plus Oxaliplatin for Gastric Cancer After D2 Gastrectomy (CLASSIC). Lancet. 2012. Source ↗
ClinicalTrials.gov NCT00411229 Source ↗