ISRCTN80416929进行中（未招募）2 期
Randomised trial comparing total thyroidectomy, thyriod stimulating hormone (TSH) suppression and radioactive iodine ablation with total thyroidectomy and TSH suppression, in low-risk patients with thyroid cancer
niversity College London (UCL) (UK)0 个研究点目标入组 504 人开始时间: 2011年3月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 504
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 06/06/2012
- •1. R0 total thyroidectomy (in 1 or 2 stages, no residual disease present)
- •2. Negative pregnancy test in females of child bearing potential
- •3. Aged 16 years or over
- •4. WHO performance status 0 ? 2, self caring
- •5. Histological confirmation of differentiated thyroid carcinoma
- •6. Papillary thyroid cancer:
- •6.1 Non agressive histological features (small foci of agressive histology allowed)
- •6.2 pT1b, 1-2cm intrathyroidal
- •6.3 pT2, 2-4cm intrathyroidal
- •6.4 pT3 intrathyroidal only
- •6.5 Multifocal carcinoma
- •7. Follicular thyroid cancer/Hürthle cell cancer (minimally invasive with capsular invasion only
- •7.1 pT1b (1-2cm) pT2 (2-4cm) intrathyroidal
- •Previous inclusion criteria
- •1. Negative pregnancy test in females of child bearing potential
- •2. Aged 16 years or over, either sex
- •3. World Health Organization (WHO) performance status 0 ? 2
- •4. R0 total thyroidectomy (in 1 or 2 stages, no residual disease present)
- •5. Histological confirmation of differentiated thyroid carcinoma
- •6. Papillary thyroid cancer:
- •6.1. Non aggressive histological features (small foci allowed)
- •6.2. T1b, 1 - 2 cm, intrathyroidal
- •6.3. T2, 2 - 4 cm, intrathyroidal
- •6.4. T3, intrathyroidal
- •6.5. No vascular invasion
- •6.6. Multifocal microcarcinoma
- •7. Follicular thyroid cancer/Hürthle cell cancer:
- •7.1. Minimally invasive (capsular invasion only)
- •7.2. Tumours 2 cm or less
排除标准
- •Current exclusion criteria as of 06/06/2012
- •1. Papillary and Follicular carcinoma which is unifocal and <1cm in size
- •2. Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is:
- •2.1. non-invasive
- •2.2. angio-invasive
- •3. Anaplastic or medullary carcinoma
- •4. R1 thyroidectomy
- •5. Patients with:
- •6. Aggressive Papillary thyroid cancer with the following features:
- •6.1 Angio-invasive
- •6.2 Widely invasive
- •6.3 Poorly differentiated
- •6.4 Anaplastic differentiation
- •6.5 Tall cell
- •6.6 Columnar cell
- •6.7 Diffuse sclerosing variants
- •7. Follicular thyroid cancer/Hürthle cell cancer with the following features:
- •7.1. Angio-invasive
- •7.2. Widely invasive
- •7.3. Poorly differentiated
- •7.4. Tumours greater than 4cm
- •8. Incomplete resection/lobectomy
- •9. Macroscopic and microscopic tumour invasion of locoregional tissues or structures
- •10. Women who are lactating
- •11. Patients who have had 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 for at least 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:
- •20.1. Unstable angina
- •20.2. Recent myocardial infarction or cerebrovascular accident (CVA)
- •20.3. Severe labile hypertension
- •21. Any patient who cannot comply with radiation protection including:
- •21.1. patients with learning difficulties
- •21.2. patients with dementia
- •21.3. patients with a tracheostomy that require nursing care
- •21.4. patients requiring frequent nursing/ medical supervision
- •Previous exclusion criteria
- •1. Pregnant women or women who are breastfeeding
- •2. Patients who have computed tomography (CT) performed with intravenous (iv) contrast less than 3 months before ablation
- •3. Previous treatment for thyroid cancer (not including surgery)
- •4. Incomplete resection/lobectomy
- •5. Local or distant metastases at diagnosis
- •6. Macroscopic and microscopic tumour invasion of locoregional tissues or structures
- •7. Anaplastic or medullary carcinoma
- 另有 4 项未显示
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