RecruitingNot ApplicableNCT04354324

Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma

Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma Patients Without Metastasis: a Double-blind Randomized Clinical Trial

Sponsor

Zhujiang Hospital

Enrollment

254 participants

Start Date

Apr 20, 2020

Study Type

INTERVENTIONAL

Conditions

Papillary Thyroid Cancer

Summary

Primary objective: The 3-years disease-free survival was compared between low-dose group (30 mCi) and high-dose group (100 mCi). Secondary objective: The successful remnant ablation, efficacy, 3-year progression-free survival and safety were compared between low-dose group (30 mCi) and high-dose group (100 mCi). Research Hypothesis：The 3-year disease-free survival of low-dose group (30mci) may not be lower than that of high-dose group (100 mci) in intermediate-risk thyroid papillary carcinoma patients with no structural or functional lesions and stimulated thyroglobulin(ps-Tg)1-20ng/ml. Study design：Single-center, randomized, double-blinded Sample size：254 patients Follow-up：The measurement of serum thyroid function, thyroglobulin/ anti-thyroglobulin antibody(Tg/TgAb) and neck ultrasonography were performed every 3-12 months during the 3 years according to patients' condition, and computerized tomography(CT) scan, positron emission tomography/computed tomography(PET/CT) and diagnostic whole-body 131I scan were added if necessary. Intervention：Randomly allocated into two groups to receive either 30 mCi (low-dose group) or 100 mCi (high-dose group ) radioiodine for post-thyroidectomy ablation therapy. Evaluation index：Primary evaluation index: The 3-year disease-free survival. Secondary evaluation index: Successful remnant ablation, efficacy, the 3-year progression-free survival and safety.

Eligibility

Min Age: 16 Years

Inclusion Criteria5

Patients with histological confirmation of intermediate-risk papillary thyroid carcinoma(PTC) according to 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer.
Differentiated Thyroid Carcinoma(DTC) patients who underwent total or near-total thyroidectomy which was consistent with the recommendations of American Thyroid Association guidelines as well as Chinese Thyroid Association guidelines on the management of Differentiated Thyroid Carcinoma(DTC).
Serum stimulated thyroglobulin was 1-20ng/ml.
At least 16 years old.
Patients who volunteered to participate in the study and signed informed consent.

Exclusion Criteria5

Ultrasonography, Computerized Tomography(CT), Magnetic Resonance Imaging(MRI) or Positron Emission Tomography/computed tomography (PET/CT) indicates the presence of lesions.
Iodine-131 whole body scan indicates the presence of lesions outside the thyroid bed.
Patients with positive thyroglobulin antibody (≥115 Ku/L).
Patients who had other coexisting serious diseases or other factors that may affect the outcome of ablation.
Pregnant or breastfeeding women, or with birth planning within six months.