IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
Conditions
Thyroid Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Papillary thyroid carcinoma, Follicular thyroid carcinoma, Hurthle cell carcinoma of the thyroid, Iodine Radioisotopes
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: I131 1.1 GBq
Type: Radiation
Overall Status
Recruiting
Summary
IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation is necessary for low risk differentiated thyroid cancer patients.
Detailed Description
Phase II: to determine if recruitment into a phase III trial is feasible, with a target of 10 patients per month during a minimum of 6 months (evaluated within months 7-18 of the trial).

Phase III: to determine whether the 5-year disease-free survival rate among patients who do not have routine Radioactive iodine (RAI) ablation is non-inferior to those who do.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: Inclusion Criteria:

- R0 total thyroidectomy (in one or two stages, no residual disease present) within the last 6 months

- Negative pregnancy test in women of child bearing potential

- Aged 16 or over

- WHO performance status 0 - 2, self-caring

- Histological confirmation of differentiated thyroid carcinoma:

- Papillary thyroid cancer

- Non aggressive histological features (small foci of aggressive histology allowed)

- PT1a(m): all individual foci ≥1cm, intrathyroidal

- pT1b and pT1b(m): >1-2cm, intrathyroidal

- pT2 and pT2(m): >2-4cm, intrathyroidal

- pT3 and pT3(m): >4cm, intrathyroidal, or any size with minimal extrathyroidal spread

- pN0

- pN1a

- pNX

- Encapsulated follicular variant of papillary thyroid cancer (EFVPTC) with capsular invasion only

- Follicular thyroid cancer/ Hürthle cell cancer

- minimally invasive with capsular invasion only

- pT1b: >1- 2 cm

- pT2: >2-4cm, intrathyroidal

Exclusion Criteria:

- Papillary and Follicular carcinoma which is unifocal and ≤1cm in size

- Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is:

- non-invasive (no capsular or vascular invasion)

- angio invasive (with definite vascular invasion)

- Anaplastic or medullary carcinoma

- R1 Thyroidectomy

- Patients with:

- pN1b

- M1

- Aggressive Papillary thyroid cancer with the following features:

- Angio invasive

- Widely invasive

- Poorly differentiated

- Anaplastic differentiation

- Tall cell

- Columnar cell

- Diffuse sclerosing variants

- Follicular thyroid cancer/ Hürthle cell cancer with the following features:

- Angio invasive

- Widely invasive

- Poorly differentiated

- Tumours greater than 4cm

- Incomplete resection/ lobectomy

- Macroscopic and microscopic tumour invasion of locoregional tissues or structures

- Pregnant women or women who are lactating

- Patients who have CT performed with iv contrast less than 3 months before ablation

- Previous treatment for thyroid cancer (except surgery)

- 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 at least for 5 years

- Dysphagia, Oesophageal stricture, Active gastritis,Gastric erosions, Peptic ulcer, Suspected reduced gastrointestinal motility

- Severe co-morbid condition/s that would prevent ablation including:

- Unstable angina

- Recent myocardial infarction or cerebrovascular accident (CVA)

- Severe labile hypertension

- Any patient who cannot comply with radiation protection including:

- patients with learning difficulties

- patients with dementia

- patients with a tracheostomy that require nursing care

- patients requiring frequent nursing/ medical supervision
Locations
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Status: Recruiting
University Hospital Bristol NHS Foundation Trust
Bristol, United Kingdom
Status: Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Status: Recruiting
Mid Essex Hospitals Services NHS Trust
Chelmsford, United Kingdom
Status: Recruiting
Gloucestershire Hospitals NHS Trust
Cheltenham, United Kingdom
Status: Recruiting
Royal Derby hospital NHS foundation trust
Derby, United Kingdom
Status: Not yet recruiting
Poole Hospital NHS Foundation Trust
Dorset, United Kingdom
Status: Recruiting
NHS Lothian
Edinburgh, United Kingdom
Status: Recruiting
Royal Devon and Exeter NHS Trust
Exeter, United Kingdom
Status: Recruiting
Glasgow and Clyde NHS Trust
Glasgow, United Kingdom
Status: Recruiting
Ipswich Hospital NHS Trust
Ipswich, United Kingdom
Status: Recruiting
East Kent Hospitals University NHS Foundation Trust
Kent, United Kingdom
Status: Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Status: Recruiting
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Status: Recruiting
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom
Status: Recruiting
Imperial College Healthcare NHS Trust
London, United Kingdom
Status: Recruiting
Royal Marsden NHS Foundation Trust
London, United Kingdom
Status: Recruiting
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Status: Recruiting
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Status: Recruiting
The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Recruiting
South Tees Hospitals NHS Trust
Middlesbrough, United Kingdom
Status: Recruiting
Velindre NHS Trust
Nant Garw, United Kingdom
Status: Recruiting
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Status: Recruiting
Norfolk and Norwich University Hospitals NHS Trust
Norwich, United Kingdom
Status: Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Status: Recruiting
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
Status: Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Status: Recruiting
Southend University Hospitals NHS Trust
Southend, United Kingdom
Status: Recruiting
East and North Herts
Stevenage, United Kingdom
Status: Not yet recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Surrey, United Kingdom
Status: Recruiting
Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
Status: Recruiting
Start Date
May 2012
Completion Date
January 2021
Sponsors
University College, London
Source
University College, London
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page