Thyroxine therapy after thyroid surgery for low-risk cancer
A Prospective, Single-arm Phase II Study of Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
This study tests if taking thyroxine after surgery for low-risk thyroid cancer can help keep patients healthy and prevent the cancer from coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Months to 70 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06087068 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of thyroxine replacement therapy in patients who have undergone lobectomy for low-risk papillary thyroid carcinoma. The study aims to control Thyroid Stimulating Hormone (TSH) levels to improve outcomes and reduce recurrence rates. Participants will be closely monitored for disease-free status following treatment. The trial focuses on patients with specific criteria, including tumor size and absence of metastasis, to ensure a targeted approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with unilateral thyroid nodules ≤4.0cm and diagnosed with low-risk papillary thyroid carcinoma.
Not a fit: Patients with a history of other malignancies or significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance disease-free survival rates for patients with low-risk papillary thyroid carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar approaches in managing thyroid cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Age 18-70 years old, ECOG score 0-2; * (2) Patients with the maximum diameter of unilateral thyroid nodules ≤4.0cm by ultrasound, papillary thyroid carcinoma diagnosed by preoperative cytology (Bethesda grade VI) or intraoperative freezing, and planned to undergo thyroid lobectomy; * (3) No clinical lymph node metastasis (cN0);No extrathyroidal extension, and the number of pathological lymph node micrometastasis (\<0.2cm) was ≤5. * (4) no serious medical diseases and major organ dysfunction, such as blood routine, liver, kidney, heart, lung function; No previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass excision except clinical); * (5) Fully understand this study, have the ability to complete treatment, have follow-up conditions and voluntarily sign informed consent. Exclusion Criteria: * (1) History of malignancy in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; * (2) The contralateral thyroid nodules were evaluated by preoperative ultrasound, and the patients with suspicious nodules who underwent fine-needle aspiration cytology and could not confirm the benign or malignant nodules (Bethesda grade I, III-V) were excluded. * (3) Cervical lymph node metastasis was evaluated before surgery. Cytological aspiration and Tg eluent determination were performed on suspicious lymph nodes. If cytology was negative and Tg eluent was not higher than the normal range, it was not considered as exclusion criteria. The patients who were sent for intraoperative examination and showed metastasis were excluded. * (4) cytological aspiration or intraoperative freezing suspected non-papillary thyroid carcinoma (follicular carcinoma, medullary carcinoma, poorly differentiated or undifferentiated carcinoma) or high-risk subtypes of papillary thyroid carcinoma (high cell type); * (5) pregnant or lactating women； * (6) A history of drug use or drug abuse within the past 1 year; * (7) Participants who had participated in other clinical trials within 4 weeks before enrollment; * (8) The patient is unable to accept the preservation of the contralateral gland or cannot cooperate with subsequent thyroid hormone replacement therapy. * (9) The investigator assesses subjects who are unsuitable for the trial for other reasons, or who are not expected to complete the study.
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: jie liu
- Email: liujie10-11@vip.163.com
- Phone: +861087787180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.