Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
Neoadjuvant Treatment With Selpercatinib in RET-Altered Thyroid Cancers
Sponsor: M.D. Anderson Cancer Center
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR)
Time frame: Up to 7 months
Tumor response
Time frame: Up to 7 months
Secondary Endpoints
R0/R1 resection rates
Progression free survival (PFS)
Locoregional PFS
Eligibility Criteria
Inclusion Criteria: * Patients with RET-altered thyroid cancer who present with locally advanced primary tumor, defined as T3 or T4 by imaging or invasive/bulky nodal disease, or with recurrent/residual invasive/bulky nodal disease will be enrolled in this trial, regardless of whether distant metastases are present or not * At least 12 years of age on the day of signing informed consent * Pathologic findings supporting the clinical impression of medullary thyroid carcinoma, papillary thyroid carcinoma, poorly differentiated thyroid carcinoma, or anaplastic thyroid carcinoma. Diagnosis of anaplastic thyroid carcinoma may include consistent with or suggestive of terminology associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present * Having an activating RET gene alteration (fusion or mutation). Th…
Read full criteria on CT.gov →✦ Analyst Commentary
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