Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer
2011

Study on Sorafenib for Thyroid Cancer

Sample size: 380 publication Evidence: moderate

Author Information

Author(s): Marcia S Brose, Christopher M Nutting, Steven I Sherman, Young Kee Shong, Johannes WA Smit, Gerhard Reike, John Chung, Joachim Kalmus, Christian Kappeler, Martin Schlumberger

Primary Institution: The University of Pennsylvania, Royal Marsden Hospital, The University of Texas MD Anderson Cancer Center, Asian Medical Center, Leiden University Medical Center, Bayer Schering Pharma AG, Bayer HealthCare Pharmaceuticals, Institut Gustave Roussy

Hypothesis

Does sorafenib improve progression-free survival in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer?

Conclusion

The DECISION trial aims to evaluate the efficacy and safety of sorafenib in improving progression-free survival in patients with advanced thyroid cancer.

Supporting Evidence

  • Sorafenib has shown median progression-free survival of 58 to 84 weeks in previous studies.
  • Partial responses were observed in up to 25% of patients treated with sorafenib.
  • Disease control rates ranged from 59% to 100% in phase II trials.

Takeaway

This study is testing a new medicine called sorafenib to see if it helps people with a type of thyroid cancer that doesn't respond to regular treatments.

Methodology

Multicenter, double-blind, randomized, placebo-controlled phase III trial.

Participant Demographics

Patients with locally advanced or metastatic differentiated thyroid cancer, including papillary, follicular, Hürthle cell, and poorly differentiated carcinoma.

Digital Object Identifier (DOI)

10.1186/1471-2407-11-349

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