Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 504
- 试验地点
- 63
- 主要终点
- Phase III: Disease-free thyroid specific survival
研究概览
简要总结
IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation is necessary for low risk differentiated thyroid cancer patients.
详细描述
Phase II: to determine if recruitment into a phase III trial is feasible, with a target of 10 patients per month during a minimum of 6 months (evaluated within months 7-18 of the trial).
Phase III: to determine whether the 5-year disease-free survival rate among patients who do not have routine Radioactive iodine (RAI) ablation is non-inferior to those who do.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Phase III: Disease-free thyroid specific survival
时间窗: From randomisation until recurrence or death from thyroid cancer
DFS measured from randomisation until date of recurrence or death from thyroid cancer
Phase II: monthly patient accrual rates
时间窗: Evaluated within months 7-18 of the trial
To determine if recruitment into a phase III trial is feasible
次要结局
- Phase III: Stage of cancer at the time of recurrence, and the ability to treat this successfully(After follow up is complete (estimated year 8-9 of trial))
- Phase III: Further neck surgery(After follow up is complete (estimated year 8-9 of trial))
- Phase III: Health-related quality of life(After follow up is complete (estimated year 8-9 of trial))
- Phase III: Cost-effectiveness(After follow up is complete (estimated year 8-9 of trial))
- Phase III: Mortality (cause and date of death)(From randomisation until death)
- Phase III: Adverse events for all patients(After follow up is complete (estimated year 8-9 of trial))
- Phase III: Occurrence of loco-regional recurrence or metastatic disease(After follow up is complete (estimated year 8-9 of trial))
- Phase III: Further RAI ablations(After follow up is complete (estimated year 8-9 of trial))