NCT02418247Unknown2 期
Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 556
- 试验地点
- 5
- 主要终点
- Biochemical Remission Rate
研究概览
简要总结
The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with differentiated thyroid cancer
- •recently underwent total thyroidectomy (within 6 months)
- •pathological criteria
- •T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci)
- •T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle)
- •T1-3N1a : 3 or less micrometastatic lymph node
排除标准
- •differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer
- •gross extension (strap muscle or more)
- •thyroid cancer with distant metastasis
- •previous remote history of thyroid cancer surgery
- •history of cervical external beam radiation therapy
- •previous history of comorbid cancer within 5 years
- •renal insufficiency (Ccr <30ml/min)
- •women with pregnancy or breast feeding
研究组 & 干预措施
low dose RAI
Active Comparator
Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
干预措施: I131 (Drug)
diagnostic RAI
Sham Comparator
Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
干预措施: I123 (Drug)
结局指标
主要结局
Biochemical Remission Rate
时间窗: within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
次要结局
未报告次要终点
研究者
Eun Kyung Lee
M.D., Ph.D.
National Cancer Center, Korea
研究点 (5)
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