# DECISION

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

## TL;DR

The first drug approved for thyroid cancers that stopped responding to radioactive iodine.

## Summary

DECISION, trial NCT00984282 sponsored by Bayer and reported in 2013, produced the first drug approved for differentiated thyroid cancers that stopped responding to radioactive iodine. It randomised 417 patients to sorafenib or placebo and met its primary progression-free survival endpoint, leading to FDA approval in November 2013, with hand-foot skin reaction and fatigue common. OnCo links it to thyroid cancer, kinase inhibitors, VEGF and BRAF as targets, the radioiodine-refractory term and Marcia S. Brose, and SELECT confirmed the class effect with a larger benefit for lenvatinib. Sorafenib has been largely displaced by lenvatinib but is still used, and whether it retains a niche in patients who cannot tolerate lenvatinib is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00984282
- Phase: 3
- Setting: Radioiodine-refractory differentiated thyroid cancer: sorafenib vs placebo
- Sponsor: Bayer
- Enrolled: 417
- Result: PFS 10.8 vs 5.8 months; HR 0.59.
- Outcomes: Progression-free survival: Sorafenib 10.8 months vs Placebo 5.8 months, HR 0.59
- Replication: SELECT confirmed the class effect with a larger benefit.

## Sources

- ClinicalTrials.gov NCT00984282: https://clinicaltrials.gov/study/NCT00984282
- Lancet 2014: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60421-9/fulltext

## Connected records

- cancers: [Thyroid cancer](https://onco.cc/cancers/thyroid/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BRAF](https://onco.cc/targets/braf/), [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- terms: [Radioiodine-refractory (RAI-R) thyroid cancer](https://onco.cc/terms/rai-refractory/)
- people: [Marcia S. Brose](https://onco.cc/people/marcia-brose/)
- key papers: [DECISION: sorafenib in radioactive iodine-refractory differentiated thyroid cancer](https://onco.cc/key-papers/paper-decision-sorafenib-lancet-2014/)

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