Using RET inhibitors before surgery for advanced thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study evaluates the use of RET inhibitors as neoadjuvant therapy in patients with locally advanced RET-altered thyroid cancer. Participants who respond to the treatment may proceed to surgical intervention. The study aims to assess both the efficacy and safety of this approach in a real-world setting, focusing on various types of thyroid cancer that exhibit RET alterations. By monitoring patient outcomes, the study seeks to provide insights into the potential benefits of this treatment strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients voluntarily join this study and sign an informed consent form;
* Age: ≥ 14 years old, male or female not limited;
* Locally advanced thyroid cancer diagnosed by histopathology, including papillary thyroid carcinoma, medullary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated/poorly differentiated thyroid carcinoma, etc;
* RET alterations, including fusion and mutations;
* The definition of locally advanced thyroid cancer meets at least one of the following criteria:

  1. Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection;
  2. T4 thyroid cancer defined by AJCC: any size of tumor primary lesion or regional lymph node infiltration beyond the thyroid capsule to subcutaneous soft tissue, larynx, trachea, esophagus, or recurrent laryngeal nerve, tumor invasion of pre vertebral fascia or wrapping around carotid or mediastinal blood vessels;
  3. According to the imaging score, the resectable probability is less than 80% based on CT.
* At least one measurable lesion;
* For patients with distant metastasis, researchers need to determine whether patients would benefit from surgery;
* Patients voluntarily undergo tumor tissue biopsy/surgery during enrollment and withdrawal;
* Normal function of major organs.

Exclusion Criteria:

* Previously used RET inhibitors;
* There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
* The patient refuses to undergo tumor tissue biopsy or surgery;
* Patients who are unsuitable for RET inhibitors or surgery.

Where it's running

• Fudan Univeristy Shanghai Cancer Center
  Shanghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.