SCOT
Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer
Phase 3N = 6,088NCT00749450
- Population
- Patients aged 18 or older with high-risk stage II or stage III colorectal cancer; 6088 randomised (intended regimen FOLFOX in 1981 and CAPOX in 4107); 3035 and 3030 in the intention-to-treat analysis after exclusions for data consent.
- Design
- International randomised phase 3 noninferiority trial at 244 centres comparing 3 with 6 months of adjuvant CAPOX or FOLFOX (regimen chosen before randomisation by patient and physician) in high-risk stage II and stage III colorectal cancer. Primary endpoint disease-free survival; noninferiority margin hazard ratio 1.13; primary analysis in the intention-to-treat population. Also registered as ISRCTN59757862. The 2026 report adds overall survival with longer follow-up.
- Primary endpoint
- DFS
- Arms
- 3 months (experimental, n = 3,035): 3 months of adjuvant oxaliplatin-containing chemotherapy
- 6 months (control, n = 3,030): 6 months of adjuvant oxaliplatin-containing chemotherapy
- People
- Iveson TJ
DFSHR 1.006 (95% CI 0.909–1.114)Δ 36-month DFS−0.4 pointsΔ Grade 2 or worse peripheral neuropathy−33 pointsOSHR 0.96 (95% CI 0.86–1.07)Δ 60-month OS0 points
Show the numbers
| Endpoint | Analysis | 3 months | 6 months | Effect |
|---|---|---|---|---|
| DFS | primaryIveson 2018 | 76.7% at 3 y (75.1–78.2%) | 77.1% at 3 y (75.6–78.6%) | HR 1.006 (95% CI 0.909–1.114)P=0.012P value is for noninferiority against a margin of HR 1.13, which the authors state was significantly exceeded in the favourable direction. 1482 disease-free survival events (740 and 742). The authors note the study was underpowered. |
| Grade 2 or worse peripheral neuropathySubset with safety data (420 in the 3-month group and 409 in the 6-month group) | primaryIveson 2018 | 25% | 58% | Percentages as rounded in the abstract: 103 of 420 (3 months) and 237 of 409 (6 months). |
| OSPatients with high-risk stage II and stage III colorectal cancer (including rectal cancer); population label not stated | finalIveson 2026 | 82.4% at 5 y | 82.4% at 5 y | HR 0.96 (95% CI 0.86–1.07)P=0.0033The P value is for noninferiority against a hazard ratio margin of 1.13. The abstract prints the lower confidence limit as 0.8; the Results text gives 0.86 (recorded). The abstract gives a median follow-up of 113 months, whereas the Results text gives 75 months (IQR 61-91, reverse Kaplan-Meier); the two disagree, so no median follow-up is recorded. The abstract concludes that noninferiority for OS was shown, that the duration effect is regimen-dependent (noninferiority for CAPOX but not FOLFOX) and that noninferiority was also shown in patients with rectal cancer (1,087 in the abstract, 1,101 in the Results text). |
| Endpoint | Analysis | 3 months | 6 months | Effect |
|---|---|---|---|---|
| DFS | primaryIveson 2018 | 76.7% at 3 y (75.1–78.2%) | 77.1% at 3 y (75.6–78.6%) | HR 1.006 (95% CI 0.909–1.114)P=0.012P value is for noninferiority against a margin of HR 1.13, which the authors state was significantly exceeded in the favourable direction. 1482 disease-free survival events (740 and 742). The authors note the study was underpowered. |
| Grade 2 or worse peripheral neuropathySubset with safety data (420 in the 3-month group and 409 in the 6-month group) | primaryIveson 2018 | 25% | 58% | Percentages as rounded in the abstract: 103 of 420 (3 months) and 237 of 409 (6 months). |
| OSPatients with high-risk stage II and stage III colorectal cancer (including rectal cancer); population label not stated | finalIveson 2026 | 82.4% at 5 y | 82.4% at 5 y | HR 0.96 (95% CI 0.86–1.07)P=0.0033The P value is for noninferiority against a hazard ratio margin of 1.13. The abstract prints the lower confidence limit as 0.8; the Results text gives 0.86 (recorded). The abstract gives a median follow-up of 113 months, whereas the Results text gives 75 months (IQR 61-91, reverse Kaplan-Meier); the two disagree, so no median follow-up is recorded. The abstract concludes that noninferiority for OS was shown, that the duration effect is regimen-dependent (noninferiority for CAPOX but not FOLFOX) and that noninferiority was also shown in patients with rectal cancer (1,087 in the abstract, 1,101 in the Results text). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 1.006 | 0.909–1.114 |
| OS | 0.96 | 0.86–1.07 |
Appears in
Sources
Iveson TJ, Kerr RS, Saunders MP, Cassidy J, Hollander NH, Tabernero J, et al. 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2018;19(4):562-578.
Iveson T, Saunders MP, Kelly C, Kerr RS, Cassidy J, Hollander NH, et al. Three Versus 6 Months of Adjuvant Oxaliplatin-Fluoropyrimidine Chemotherapy for Colorectal Cancer: Final Results of SCOT-An International, Randomized, Phase III, Noninferiority Trial. J Clin Oncol. 2026;44(7):534-539.