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:
1. Radioactive iodine (RAI) ablation arm (1.1 GBq), or
2. No ra
Sponsors
University College London (UCL) (UK)
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 6.6 pN0 6.7 pN1a 6.8 pNX 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 6.7. N0 6.8. N1a 6.9. NX 7. Follicular thyroid cancer/Hürthle cell cancer: 7.1. Minimally invasive (capsular invasion only) 7.2. Tumours 2 cm or less 7.3. N0 7.4. N1a 7.5. NX
Exclusion criteria
Exclusion criteria: 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: 5.1 pN1b 5.2 M1 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 8. Patients with: 8.1. N1b 8.2. M1 9. Previous malignancies with limited life expectancy likely to interfere with the patient's ability to be able to comply with treatment and/or follow-up 10. Severe co-morbid condition/s that would prevent ablation including: 10.1. Unstable angina 10.2. Recent myocardial infarction or cerebrovascular accident (CVA) 10.3. Severe labile hypertension 10.4. Any patient who cannot comply with radiation protection including: 10.4.1. Patients with learning difficulties 10.4.2. Patients with dementia 10.4.3. Patients with a tracheotomy that require nursing care 10.4.4. Patients requiring frequent nursing/ medical supervision 11. Papillary thyroid cancer that is: 11.1. Widely invasive 11.2. Poorly differentiated 11.3. Tall cell 11.4. Columnar cell 11.5. Diffuse sclerosing variants 12. Follicular thyroid cancer/Hürthle cell cancer that is: 12.1. Widely invasive 12.2. Poorly differentiated 12.3. Tumours greater than 2 cm 12.4. Diffuse sclerosing variants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phase II: monthly patient accrual rates, evaluated 7 - 18 months after the start. There will then be a decision on whether to proceed to phase III or not 2. Phase III: 5-year recurrence-free survival, evaluated after the last patient has their last follow-up or sooner depending on the data | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure (s) as of 06/06/2012: Phase III only (evaluated by the statistician at the final analysis at the end of the study): 1. Quality of life (E5-QD, QLQ-C30, H&N35) 2. Adverse events (Common Toxicity Criteria for Adverse Events [CTCAE]) 3. Thyroid cancer mortality 4. Loco-regional recurrence 5. Distant metastases 6. Incidence of second primary tumours Analysis will depend on recruitment but if the trial goes to phase III we expect all patients to be recruited in 3 - 4 years so last visit and analysis will be 8-9 years after the start. Previous secondary outcome measure (s): Phase III only (evaluated by the statistician at the final analysis at the end of the study): 1. Quality of life (E5-QD and SF-36) 2. Adverse events (Common Toxicity Criteria for Adverse Events [CTCAE]) 3. Thyroid cancer mortality 4. Loco-regional recurrence 5. Distant metastases 6. Incidence of second primary tumours Analysis will depend on recruitment but if the trial goes to phase III we expect all patients to be recruited in 3 - 4 years so last visit and analysis will be 8-9 years after the start. | — |
Countries
England, United Kingdom
Outcome results
None listed