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

NCT04354324 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Papillary Thyroid Cancer

Interventions

DRUG

Radioiodine

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

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Huijuan Feng, Master · Southern Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04354324 on ClinicalTrials.gov