Differentiated thyroid cancer Cancer Thyroid cancer
Conditions
Interventions
Following surgery, eligible patients will be approached for consent. Those who agree will be randomised to one of the following groups:
Group A: rhTSH followed by 1.1 GBq of radioiodine ablation
Group
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who have a successful remnant ablation six to eight months after radioiodine administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life during treatment period 2. Loco-regional recurrence 3. Distant metastases Long term outcomes: 1. Survival and incidence of secondary primary malignancies | — |
Countries
United Kingdom
Outcome results
None listed