RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer

NCT06530316 | Recruiting FDA Drug

• 1 other identifier: PATHYOID
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• R0/1 resection rate

  1 year

Secondary Outcomes (6)

• Objective Response Rate, ORR

  1 year

• Disease Control Rate，DCR

  1 year

• Time to objective response，TTR

  1 year

• Progression Free Survival，PFS

  5 years

• Overall Survival，OS

  5 years

Study Arms (2)

None MTC

DTC, PDTC and ATC patients with RET fusions.

Drug: RET Inhibitor; Procedure: Surgery

MTC

MTC patients with RET mutations

Drug: RET Inhibitor; Procedure: Surgery

Interventions

RET Inhibitor DRUG

RET inhibitors for neoadjuvant treatment

MTC; None MTC

Surgery PROCEDURE

Operable patients receive surgery after neoadjuvant therapy

MTC; None MTC

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced thyroid cancer and RET alterations, who require RET inhibitor treatment and surgery after neoadjuvant therapy.

You may qualify if:

• 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:
• Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection;
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: July 18, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

CN (1)