EUCTR2011-000144-21-GB进行中（未招募）不适用
ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients - Io
niversity College London0 个研究点目标入组 570 人开始时间: 2011年7月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 570
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.R0 total thyroidectomy completed within 6 months prior to randomisation(for 2 stage TTs only the second stage must have been carried out within the 6 month timeframe)
- •2.Negative pregnancy test in women of child bearing potential
- •3.Aged 16 or over
- •4.WHO performance status 0 – 2, self- caring
- •5.Histological confirmation of differentiated thyroid carcinoma:
- •Papillary thyroid cancer
- •a.Non aggressive histological features (small foci of aggressive histology allowed)
- •b.pT1a(m): all individual foci =1cm, intrathyroidal
- •c. pT1b and pT1b(m): >1-2cm, intrathyroidal
- •d.pT2 and pT2(m):>2-4cm, intrathyroidal
- •e.pT3 and pT3(m): .4cm, inrtathyroidal, or any size with minimal extrathyroidal extension
- •i. Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) with capsular invasion only
- •Follicular thyroid cancer/ Hürthle cell cancer (minimally invasive with capsular invasion only)
- •a.pT1b: >1-2cm ,intrathyroidal
- •b. pT2: >2-4cm, intrathyroidal
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 532
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.pT1a - Papillary and Follicular carcinoma which is unifocal and = 1cm in size
- •2.Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is:
- •a.non-invasive (no capsular or vascular invasion)
- •b.angio invasive (with definite vascular invasion)
- •3.Anaplastic or medullary carcinoma
- •4.R1 Thyroidectomy
- •5.Patients with:
- •6.Aggressive Papillary thyroid cancer with the following features:
- •a.Angio invasive
- •b.Widely invasive
- •c.Poorly differentiated
- •d.Anaplastic differentiation
- •e.Tall cell
- •f.Columnar cell
- •g.Diffuse sclerosing variants
- •7.Follicular thyroid cancer/ Hürthle cell cancer with the following features:
- •a.Angio invasive
- •b.Widely invasive
- •c.Poorly differentiated
- •d.Tumours greater than 4cm
- •8.Incomplete resection/ lobectomy
- •9.Macroscopic and microscopic tumour invasion of locoregional tissues or structures
- •10.Pregnant women or women who are lactating
- •11.Patients who have CT performed with iv contrast less than 3 months before ablation
- •12.Previous treatment for thyroid cancer (except surgery)
- •13.Previous malignancies with limited life expectancy or likely to interfere with the patient’s ability to be able to comply with treatment and/or follow-up at least for 5 years
- •14.Dysphagia
- •15.Oesophageal stricture
- •16.Active gastritis
- •17.Gastric erosions
- •18.Peptic ulcer
- •19. Suspected reduced gastrointestinal motility
- •20.Severe co-morbid condition/s that would prevent ablation including:
- •a.Unstable angina
- •b.Recent myocardial infarction or cerebrovascular accident (CVA)
- •c.Severe labile hypertension
- •d.Any patient who cannot comply with radiation protection including:
- •i.patients with learning difficulties
- •ii.patients with dementia
- •iii.patients with a tracheostomy that require nursing care
- •iv.patients requiring frequent nursing/ medical supervision
研究者
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