Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma Patients Without Metastasis: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
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.
详细描述
Intermediate risk papillary thyroid carcinoma(PTC) patients with no structural and functional lesions and stimulated thyroglobulin( s-Tg) 1-20ng/ml were randomly divided into low-dose group (30 mCi) and high-dose group (100 mCi). The 3-years disease-free survival was compared between two groups.The successful remnant ablation, efficacy, 3-year progression-free survival and safety (short-term and long-term adverse reactions) were compared between two groups (30mci, 100mci).The 3-year disease-free survival of low-dose group (30mci) may not be lower than that of high-dose group (100mci) in intermediate-risk thyroid papillary carcinoma patients with no structural or functional lesions and stimulated thyroglobulin 1-20ng/ml.This study is a single-center, randomized, double-blind parallel controlled study initiated by Southern Medical University. The follow-up period was 3 years.The study was divided into two groups: the test group (30mci) and the control group (100mci). And the subjects were randomly assigned to the test group or the control group. This study is a double-blind trial. The specification of the outer packaging of the control drug is the same as that of the test drug, and the subjects are blinded. According to literature reports and pre-clinical data, the disease-free survival of the control group was 92%, non-inferiority cutoff value was δ = 7%, A total of 254 subjects are generated from a=0. 025 (one-sided test), Power=0.8, proportion=0.5(control group) and lost rate =10% (two groups) by Power Analysis and Sample Size(PASS) software. Patients admitted to the department for 131I therapy are recruited by means of propaganda, science popularization and so on. A total of 254 patients with PTC were enrolled in the study which was conducted in the Nuclear Medicine Department, Zhujiang Hospital of Southern Medical University from June 2019 to June 2024. The test group: low dosage (30mci).The control group: high dosage (100mci).The name, appearance and packaging of the test group and the control group are the same, the dosage forms are different, but participants can be made into the same volume. Therefore, the products of two groups can not be distinguished with the naked eye but measuring instruments. Subjects must be screened within one week before random enrollment. The informed consent of the patient will be obtained after a detailed explanation of the study to each subject and before any screening process or evaluation.
During the screening visit, the following procedures will be carried out / the following information will be collected:
Demographic characteristics (Include date of birth, gender and race); Medical and treatment history; Operation and postoperative pathology; Vital signs（breath/ pulse /blood pressure/ pulse rate）; Physical examination; Lab examination (hematology/biochemistry/urinalysis); Thyroid function test; Tg / TgAb; Tumor markers; Pregnancy test (fertile women); 12-Lead Electrocardiogram; Neck ultrasonography; CT of neck and chest; 131I whole-body scan; Neck MRI (not-required item, performed when neck ultrasonography suggests suspicious lymph nodes but can not be diagnosed).
Combined medications and adverse events record Treatment Stage 1(V2,0) Vital signs（breath/ pulse /blood pressure/ pulse rate）; Physical examination; Lab examination (hematology/biochemistry/urinalysis); Thyroid function test; Tg/TgAb; 12-Lead Electrocardiogram; Neck ultrasonography; 131I whole-body scan; Combined medications and adverse events record. Following Stage(V(n+1),8 weeks±n day（s)） Lab examination (hematology/biochemistry/urinalysis); Thyroid function test; Tg/TgAb; Tumor markers; Neck ultrasonography; CT of neck and chest; 131I whole-body scan; Neck MRI (not a necessary item, performed when neck ultrasonography suggest suspicious lymph nodes but can not be diagnosed); PET/CT(not a necessary item,performed when stimulated thyroglobulin >10ng/ml and 131I whole body scan negative) Combined medications and adverse events record. Observation Index
(1) Effectiveness observation Index: disease-free survival, successful remnant ablation, efficacy, Progression-free survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The test group
Oral administration of 30mci once on an empty stomach.
干预措施: Radioiodine (Drug)
The control group
Oral administration of 100mci once on an empty stomach.
干预措施: Radioiodine (Drug)
结局指标
主要结局
disease-free survival
时间窗: 3-year
The 3-years disease-free survival was compared between low-dose group (30 mCi) and high-dose group (100 mCi)
次要结局
未报告次要终点
研究者
Huijuan Feng
Deputy chief physician
Zhujiang Hospital