Multicentre randomised trial of High dose versus Low dose radioiodine, with or without recombinant human thyroid stimulating hormone, for remnant ablation following surgery for differentiated thyroid cancer

niversity College London (UK)0 个研究点目标入组 468 人开始时间: 2006年9月11日最近更新: 2018年11月12日

适应症

试验速览

•1. Histological confirmation of differentiated thyroid carcinoma
•2. Patients with tumour stage pT1-T3; NX, N0 or N1; M0 (TNM Classification of Malignant Tumours 6th edition 2002)
•3. Patients who have undergone total thyroidectomy with or without lymph node dissection
•4. Patients who require radioiodine ablation
•5. Aged 16 to 80 years
•6. World Health Organization (WHO) performance status zero to two (self caring)
•7. All known tumour resected (R0)

•1. Hurthle cell carcinoma and aggressive variants including tall cell, insular, poorly differentiated, diffuse sclerosing and widely invasive subtypes; anaplastic and medullary carcinoma
•2. Patients who have a contrast Computed Tomography (CT) scan up to three months before ablation
•3. Patients for whom rhTSH requirement is mandatory
•4. Patients who have severe co-morbid conditions (e.g., unstable angina, recent heart attack or stroke, severe labile hypertension, dementia, on dialysis, with tracheostomy needing care, learning difficulties and anybody who may not be able to comply with radiation protection issues or need frequent nursing/medical supervision which puts staff at risk of unacceptable radiation exposure)
•5. Other cancers excluding basal cell carcinoma of the skin or in situ carcinoma of the cervix
•6. Pregnant women or women who are breastfeeding
•7. Patients with stage pT4 or M1 (if detected clinically or by other investigations)
•8. Previous 131I or 123I pre-ablation scan
•9. Previous treatment for thyroid cancer (except surgery)

发起方

niversity College London (UK)