RecruitingPhase 2NCT06087068

Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma

A Prospective, Single-arm Phase II Study of Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

140 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and the number of pathological lymph node micrometastases (\<0.2cm) ≤5 were defined as the low recurrence risk group. After total thyroidectomy and radioiodine treatment, the probability of disease-free status (irritant Tg\<1ng/ml, no evidence of other disease recurrence) is about 78%-91%, and the probability of structural recurrence is about 1%-10%. In recent years, due to the further understanding of PTC, surgeons tend to become more conservative in treatment, such as active observation or reducing the extent of surgery. The indication for lobectomy has been extended to tumors \<4cm without extrathyroidal extension and clinical lymph node metastasis. For patients treated with lobectomy, current guidelines recommend that Thyroid Stimulating Hormone (TSH) be controlled at 0.5-2 mU/L, but evidence on the prognostic benefits of this TSH inhibition range is lacking.In recent years, a number of studies have suggested that if postoperative TSH in low-risk patients after lobectomy is acceptable within the reference range, it means that a considerable number of patients have a high probability of not receiving thyroxine replacement therapy after surgery, which can significantly improve their quality of life.A previous retrospective study from our institute showed no significant association between TSH levels after lobectomy and prognosis.The aim of this study was to evaluate the benefits and risks of postoperative TSH levels within the reference range (0.4-5 mU/L) in patients with low-risk papillary thyroid cancer who underwent lobectomy.In order to improve the effect of longer recurrence and death time of PTC, the investigators also performed postoperative thyroglobulin and its antibody for short-term treatment response evaluation.


Eligibility

Min Age: 18 MonthsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether thyroid hormone replacement therapy after partial thyroid removal (lobectomy) is beneficial for people with low-risk papillary thyroid cancer. Papillary thyroid cancer is the most common type of thyroid cancer, and researchers want to know if replacing hormone levels after a partial removal leads to better long-term outcomes. **You may be eligible if...** - You are between 18 and 70 years old - You have a thyroid nodule up to 4 cm confirmed as papillary thyroid cancer - You are planning to have a thyroid lobectomy (partial removal) - Your cancer has not spread to nearby lymph nodes in a significant way - You have no prior history of other head and neck cancers or neck radiation **You may NOT be eligible if...** - You have cancer in another part of your body - Your cancer has already spread to distant organs - You have serious heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGThyroxine

The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)


Locations(1)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06087068


Related Trials