Conversion Surgery After Molecular Targeted Therapy for Unresectable Thyroid Cancer

UMIN ID: UMIN000050563

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable Thyroid Cancer
• Date of first enrollment: 2023/03/17
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Conversion surgery is performed for local control if the tumor is resectable after molecular targeted therapy approved in Japan (i.e., Selpercatinib, Lenvatinib, Sorafenib, or dabrafenib/trametinib).

Outcome(s)

• Primary Outcome: Rate of conversion surgery
• Secondary Outcome: Rate of local resection (R0/1/2), Locoregional progression-free survival, Overall survival, Progression-free survival, Treatment-related death, Perioperative complications, and Combined resection of other organs.

Key inclusion & exclusion criteria

• Age minimum: 12years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Recurrent case 2) The cases with tumor invasion reaching into tracheal/esophageal/laryngeal/ pharyngeal lumen (i.e., the superficial layers of these organs) or large vessels. 3) Having any contraindications for all molecularly targeted drugs planned to use. 4) Patients unable to withstand surgery. 5) Psychiatric disease 6) Eastern Cooperative Oncology Group performance status (PS) of 3 or 4 7) Pregnancy or lactation 8) Any other cases that are regarded as inadequate for study enrollment by the investigator.

Related Information

• Primary Sponsor: Ito Hospital
• Source(s) of Monetary Support: Ito Hospital