Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorNational Cancer Center, Korea
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Hyperthyroidism
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
Design model
Parallel
Treatments tested in this trial
Levothyroxin
DrugDuring the five-year study intervention period, thyroid hormone (oral administration) supplementary doses are determined according to a dose-adjustment protocol established for the group's target TSH range.
Treatment groups
578 Participants
are divided into 2 treatment groupsGroup A: low TSH groupExperimental treatment 1 intervention
Group B: high TSH groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Disease progression
The rate of disease progression will be assessed as the proportion (%) of patients with biopsy-confirmed recurrence, based on suspicious findings identified through thyroid (neck) ultrasound performed at 6- to 12-month intervals.
Time frame
at 3,5years after enrollmentSecondary outcomes
1
Disease free survival
As the time interval from enrollment to either disease progression or all-cause mortality, whichever occurs first.
Time frame
at 3,5years after enrollment2
Disease specific survival
As the time from the date of enrollment to disease-specific mortality.
Time frame
at 3,5years after enrollment3
Overall Survival
As the time from the date of enrollment to death.
Time frame
at 3,5years after enrollment4
Target-TSH-level achievement rate
Comparison of between the low-TSH and high-TSH groups at each follow-up visit regarding the presence or absence of thyroid hormone use and its dosage, considering body weight and medication adherence, in order to achieve the target TSH concentration.
Time frame
at 3,5years after enrollmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Korea
Lead sponsor
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: