Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients. (MAeSTro-TSH)

National Cancer Center (NCC)

Status: Not yet enrolling

Conditions: Papillary Thyroid Carcinoma; Thyroid Cancer

Treatments: Drug: Levothyroxin

Study type: Interventional

Funder types: Other

Identifiers

NCT06971965

2025-0173

Details and patient eligibility

About

This study is a multicenter randomized controlled trial conducted in Korea. A parallel, two-group randomized design will be with thyroid stimulating hormone suppression therapy group(low TSH group; intervention) is different from the wIthout thyroid stimulating hormone (TSH) suppression therapy group(high TSH group; control).

Full description

Patients diagnosed with papillary thyroid cancer who wanted Active surveillance and meet the inclusion / exclusion criteria will be randomized 1: 1 into two groups: the high TSH and low TSH group. During the study period, thyroid hormone supplementary doses will be determined according to the dose-adjustment protocol established for each target TSH range.

Enrollment: 578 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
• Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).
• Non-pregnant women of childbearing potential (confirmed by medical history taking)

Exclusion criteria

• Hyperthyroidism

• If the investigator determines that you are not suitable for clinical research participation considering the following comorbidities:

  • Myocardial infarction or cerebrovascular accident within the last three months.
  • Diseases with limited life expectancy or potentially impairing the patient's ability to comply with at least five years of treatment or follow-up.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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578 participants in 2 patient groups

low TSH group

Experimental group

Description:

0.3 ≤ target TSH \<2.0mIU/L

Treatment:

Drug: Levothyroxin

high TSH group

Experimental group

Description:

2.0 ≤ target TSH \<8.0mIU/L

Treatment:

Drug: Levothyroxin