# MOSAIC

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

## TL;DR

The trial that put oxaliplatin into chemotherapy after bowel cancer surgery. It cut recurrences by a fifth and, in stage III disease, lengthened life.

## Summary

MOSAIC randomised 2,246 patients who had undergone curative resection for stage II or III colon cancer to six months of fluorouracil and leucovorin with or without oxaliplatin. Disease-free survival at three years was 78.2 against 72.9 percent (hazard ratio 0.77, p=0.002). At six years overall survival was 78.5 against 76.0 percent (hazard ratio 0.84, p=0.046); the gain was confined to stage III disease (72.9 against 68.7 percent, hazard ratio 0.80, p=0.023) with no difference in stage II. Grade 3 sensory neuropathy affected 12.4 percent during treatment and 1.1 percent at one year, and this cumulative neurotoxicity is what the IDEA duration question later tried to avoid. MOSAIC is the reason adjuvant FOLFOX or CAPOX is offered for stage III colon cancer and the reason stage II disease is treated only when risk factors are present.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: Multicenter International Study of Oxaliplatin/5-FU-LV in the Adjuvant Treatment of Colon Cancer
- Registry id: NCT00275210
- Phase: 3
- Setting: Stage II or III colon cancer after curative resection: FOLFOX4 for six months against fluorouracil and leucovorin alone
- Sponsor: Sanofi
- Enrolled: 2246
- Result: Three-year disease-free survival 78.2 against 72.9 percent (hazard ratio 0.77); six-year overall survival benefit in stage III only.
- Outcomes: Disease-free survival at 3 years: FOLFOX4 78.2 percent vs Fluorouracil and leucovorin 72.9 percent, HR 0.77; Overall survival at 6 years (stage III): FOLFOX4 72.9 percent vs Fluorouracil and leucovorin 68.7 percent, HR 0.8
- Replication: Confirmed by NSABP C-07 and, for capecitabine plus oxaliplatin, by NO16968/XELOXA; the duration was later shortened for low-risk disease by the IDEA collaboration.

## Sources

- ClinicalTrials.gov NCT00275210: https://clinicaltrials.gov/study/NCT00275210
- MOSAIC: oxaliplatin, fluorouracil and leucovorin as adjuvant treatment for colon cancer (New England Journal of Medicine 2004): https://doi.org/10.1056/NEJMoa032709
- MOSAIC six-year overall survival (Journal of Clinical Oncology 2009): https://doi.org/10.1200/JCO.2008.20.6771

## 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/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- companies: [Sanofi](https://onco.cc/companies/sanofi/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [CHALLENGE (CCTG CO.21)](https://onco.cc/trials/challenge/), [IDEA collaboration](https://onco.cc/trials/idea-collaboration/), [PETACC-3](https://onco.cc/trials/petacc-3/)

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