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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two doses of radioiodine (a type of radiation given after thyroid surgery) in patients with intermediate-risk thyroid cancer, to find the lowest effective dose. The goal is to destroy any remaining thyroid tissue after surgery while minimizing side effects. **You may be eligible if:** - You have been diagnosed with intermediate-risk papillary thyroid cancer (a common, treatable form of thyroid cancer) - You have had your thyroid completely or nearly completely removed - Your thyroglobulin level (a blood marker for remaining thyroid tissue) is between 1 and 20 ng/mL - You are at least 16 years old - You have voluntarily agreed to participate **You may NOT be eligible if:** - Imaging studies (ultrasound, CT, MRI, or PET) show remaining cancer deposits or spread to lymph nodes or other organs - You have had previous radioiodine treatment - You are pregnant or planning to become pregnant - You have conditions that interfere with how the treatment works 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.

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Interventions

DRUGRadioiodine

The test group: low dosage (30mci). The control group: high dosage (100mci).


Locations(1)

Huijuan Feng

Guangzhou, Guangdong, China

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NCT04354324


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