¿Es posible incrementar la supervivencia global en cáncer diferenciado de tiroides tras la refractariedad al radioiodo?

DECISION Trial:

Sorafenib Versus Placebo in Locally Advanced/Metastatic RAI-Refractory DTC

•

An international, multicenter, randomized, double-blind, phase 3 study of sorafenib versus placebo in patients with

locally advanced/metastatic RAI-refractory DTC

1,2

Placebo

Sorafenib

400 mg PO BID

PFS

(primary endpoint)

Investigator’s decision

Off

study

Unblind

Sorafenib

(crossover or continue)

Follow-up until disease

progression

Patients

• Locally advanced or

metastatic DTC

• Progression within

14 months

• RAI-refractory

• ≥ 1 measurable lesion

• No prior anticancer treatment

• ECOG PS ≤ 2

Randomization (1:1)

BID, twice daily; ECOG PS, Eastern Cooperative Oncology Group performance status; PO, by mouth.

Additional patient eligibility criteria exist.

1. ClinicalTrials.gov identifier # NCT00984282.

2. Brose MS, et al.

Lancet.

2014;384(9940):319-328.