# PETACC-8

Source: https://onco.cc/trials/petacc-8/  
OnCo record `petacc-8` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the EGFR antibody cetuximab to chemotherapy after surgery did not help, even in patients whose tumours had no KRAS mutation.

## Summary

PETACC-8 randomised 2,559 patients with resected stage III colon cancer in 340 European centres to FOLFOX4 with or without cetuximab. In the 1,602 patients with KRAS exon 2 wild-type tumours, disease-free survival was no different (hazard ratio 1.05, 95% CI 0.85 to 1.29, p=0.66), and there was no benefit in the KRAS exon 2 and BRAF wild-type subgroup either (0.99, 0.76 to 1.28). Grade 3 or 4 acne-like rash affected 27 percent of the cetuximab group. With N0147 reaching the same conclusion in North America, the two trials closed the question: anti-EGFR antibodies work in metastatic left-sided RAS wild-type disease and have no place in the adjuvant setting.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Registry id: NCT00265811
- Phase: 3
- Setting: Resected stage III colon cancer: FOLFOX4 with or without cetuximab
- Sponsor: Fédération Francophone de Cancérologie Digestive
- Enrolled: 2559
- Result: No disease-free survival benefit from cetuximab in KRAS wild-type disease (hazard ratio 1.05).
- Outcomes: Disease-free survival (KRAS exon 2 wild-type): FOLFOX4 plus cetuximab 1.05 hazard ratio vs FOLFOX4 1 hazard ratio, HR 1.05
- Replication: Same result as Alliance N0147 in North America.

## Sources

- ClinicalTrials.gov NCT00265811: https://clinicaltrials.gov/study/NCT00265811
- PETACC-8: FOLFOX4 with or without cetuximab in resected stage III colon cancer (Lancet Oncology 2014): https://doi.org/10.1016/S1470-2045(14)70227-X

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [KRAS](https://onco.cc/targets/kras/)
- drugs: [Cetuximab](https://onco.cc/drugs/cetuximab/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- trials: [Alliance N0147](https://onco.cc/trials/n0147/), [ATOMIC (Alliance A021502)](https://onco.cc/trials/atomic/)
- terms: [Colorectal cancer: the failed and stopped programmes, and why](https://onco.cc/terms/colorectal-failed-programmes/)

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