A Phase 3, Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Postoperative Participants With Differentiated Thyroid Cancer (DTC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- The rate of successful postoperative thyroid ablation
研究概览
简要总结
This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily sign the informed consent form (ICF).
- •Age ≥ 18 years old, either male or female.
- •Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M
- •Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- •Expected life expectancy is greater than 12 weeks;
- •Patients with a total or near-total thyroidectomy within 12 months prior to randomized.
- •Low iodine diet for two weeks prior to randomized.
排除标准
- •patients with recent history of 131I whole body scan within 2 weeks prior to randomized.
- •Pregnant or breast feeding women.
- •patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
- •Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
- •Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
研究组 & 干预措施
Thyroid hormone withdrawal group
After randomization, patients with thyroid hormone withdrawal therapy(i.e. Stop taking thyroid hormone for 14 days, and then monitor the level of thyroid-stimulating hormone every week). When TSH>30mU/L, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.
干预措施: Radioiodine (131I) (Radiation)
rhTSH group
Patients received thyroid hormone suppression therapy (Euthyrox) . rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.
干预措施: Radioiodine (131I) (Radiation)
rhTSH group
Patients received thyroid hormone suppression therapy (Euthyrox) . rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.
干预措施: rhTSH (Biological)
结局指标
主要结局
The rate of successful postoperative thyroid ablation
时间窗: 8 months later by a rhTSH stimulated radioiodine scan
Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan
次要结局
未报告次要终点