ION - Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients?

Phase 2

• Conditions: Differentiated thyroid cancer; Cancer; Thyroid cancer

• Registration Number: ISRCTN80416929
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-03
• Last Update Posted: 4 December 2023
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 504

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Phase III: 5-year recurrence-free survival, evaluated after the last patient has their last follow-up or sooner depending on the data<br>