# TOSCA

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

## TL;DR

The Italian duration trial could not show that three months was as good as six, and it is the reason the pooled answer depends on which drug combination is used.

## Summary

TOSCA accrued 3,759 patients with stage II or III colon cancer to three or six months of FOLFOX4 or CAPOX. At a median seven years the hazard ratio for relapse-free survival of three against six months was 1.13 (95% CI 0.99 to 1.29), crossing the prespecified non-inferiority limit of 1.20, so inferiority of the shorter arm could not be ruled out; the hazard ratio for overall survival was 1.09 (0.93 to 1.26, p=0.288 for superiority) with no significant difference between groups. TOSCA pulls against SCOT in the IDEA pooled analysis, and the difference between their regimen mixes, mostly CAPOX in SCOT and more FOLFOX in TOSCA, is part of why three months holds for CAPOX and not for FOLFOX.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-24
- Also known as: Three Or Six Colon Adjuvant
- Registry id: NCT00646607
- Phase: 3
- Setting: Stage II or III colon cancer after resection: three months of FOLFOX4 or CAPOX against six months
- Sponsor: Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente
- Enrolled: 3759
- Result: Relapse-free survival hazard ratio 1.13 for three against six months, crossing the non-inferiority limit; no overall survival difference.
- Outcomes: Relapse-free survival: 3 months 1.13 hazard ratio vs 6 months 1 hazard ratio, HR 1.13

## Sources

- ClinicalTrials.gov NCT00646607: https://clinicaltrials.gov/study/NCT00646607
- TOSCA: overall survival with 3 or 6 months of adjuvant chemotherapy (Annals of Oncology 2021): https://doi.org/10.1016/j.annonc.2020.10.477

## 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: [Capecitabine](https://onco.cc/drugs/capecitabine/), [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [IDEA collaboration](https://onco.cc/trials/idea-collaboration/), [SCOT](https://onco.cc/trials/scot/)

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JSON: https://onco.cc/api/v1/entities/tosca.json