# PETACC-3

Source: https://onco.cc/trials/petacc-3/  
OnCo record `petacc-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Irinotecan works in advanced bowel cancer and does nothing after surgery. The trial's tumour bank turned out to be worth more than its result.

## Summary

PETACC-3 tested whether irinotecan added to biweekly infusional fluorouracil and leucovorin improves adjuvant treatment of colon cancer. In the principal analysis of 2,094 treated stage III patients, five-year disease-free survival was 56.7 percent with irinotecan against 54.3 percent without (log-rank p=0.106) and five-year overall survival 73.6 against 71.3 percent (p=0.094); irinotecan increased grade 3 to 4 gastrointestinal events and neutropenia. With CALGB 89803 reaching the same conclusion, irinotecan was abandoned in the adjuvant setting, and the pattern, that a drug active in metastatic disease can add nothing to surgery, repeated itself later with cetuximab and with bevacizumab. The trial's large annotated tumour bank became one of the main sources for the prognostic work on microsatellite instability, BRAF and the gene-expression subtypes that became the consensus molecular subtypes.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Registry id: NCT00026273
- Phase: 3
- Setting: Stage II and III colon cancer after resection: biweekly infusional fluorouracil and leucovorin with or without irinotecan
- Sponsor: Pan-European Trials in Alimentary Tract Cancer / Pfizer
- Enrolled: 2094
- Result: Five-year disease-free survival 56.7 against 54.3 percent (p=0.106); no overall survival gain.
- Outcomes: Disease-free survival at 5 years (stage III): Irinotecan with LV5FU2 56.7 percent vs LV5FU2 54.3 percent
- Replication: CALGB 89803 also found no benefit from adjuvant irinotecan.

## Sources

- ClinicalTrials.gov NCT00026273: https://clinicaltrials.gov/study/NCT00026273
- PETACC-3: irinotecan added to adjuvant fluorouracil and leucovorin in stage III colon cancer (Journal of Clinical Oncology 2009): https://doi.org/10.1200/JCO.2008.21.6663

## 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/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/)
- terms: [Consensus molecular subtypes (CMS1-4)](https://onco.cc/terms/cms-subtypes/), [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [Alliance N0147](https://onco.cc/trials/n0147/), [MOSAIC](https://onco.cc/trials/mosaic/)

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