IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
NCT ID: NCT01398085
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
504 participants
INTERVENTIONAL
2012-05-31
2031-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radioactive iodine (RAI) ablation Arm
Patients will be randomised to receive Radioactive iodine (RAI) ablation I131 1.1 GBq
I131 1.1 GBq
Radio-iodine
No Radioactive iodine (No-RAI) ablation
Patients will be randomised to receive No Radioactive iodine (No-RAI) ablation
No interventions assigned to this group
Interventions
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I131 1.1 GBq
Radio-iodine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* R0 total thyroidectomy (in one or two stages, no residual disease present; Rx at the discretion of the MDT) 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:MDT decision for inclusion based on overall clinico-pathological assessment
* Papillary thyroid cancer (PTC):
* Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
* pT1a (≤1cm) unifocal with positive level VI lymph nodes (pN1a)
* pT1a(m): all individual foci ≤1cm
* pT1b and pT1b(m): \>1-2cm
* pT2 and pT2(m): \>2-4cm
* pT3 and pT3(m): \>4cm confined to the thyroid
* pT3 R0 +/- (m): any size with minimal ETE if recommended by the MDT
* pN0
* pN1a
* pNX
* Follicular thyroid cancer (FTC) (including oncocytic or Hürthle cell cancer):
o minimally invasive FTC -which are considered low risk and are recommended by the specialist MDT based on overall clinico-pathological assessment
* pT1b and pT2: \>1-4cm intrathyroidal
* pT3 R0:any size up to 4 cm with minimal ETE if recommended by the MDT
* Histological material available for Central Review (see section 9.7)
* Willing to use contraception for the duration of the trial until 6 months post radioiodine treatment (for females) or 4 months post treatment (for males) (see section 6.4.2), if allocated to the ablation group.
NB: Multifocal tumours (≥2 foci) of all histological types should be designated with "(m)", and the size of the largest focus determines the classification (as described in the TNM 7th edition). For example, if there are two foci, one 0.8cm and the other 3cm, the classification is based on the 3cm focus; i.e. pT2(m).
* Histological confirmation of well differentiated thyroid carcinoma: MDT decision for inclusion based on overall clinico-pathological assessment is critical.
* R0 total thyroidectomy (in one or two stages, no residual disease present; Rx at the discretion of the MDT) 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:MDT decision for inclusion based on overall clinico-pathological assessment
* Papillary thyroid cancer (PTC):
* Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
* pT1a (≤1cm) unifocal with positive level VI lymph nodes (pN1a)
* pT1a(m): all individual foci ≤1cm
* pT1b and pT1b(m): \>1-2cm
* pT2 and pT2(m): \>2-4cm
* pT3a and pT3a(m): \>4cm confined to thyroid
* pT1a/1b/2/3 (where minimal microscopic extra thyroidal extension (ETE) does not change the T score) +/- (m): any size with minimal ETE if recommended by the MDT
* pN0
* pN1a
* pNX
* Follicular thyroid cancer (FTC) (including oncocytic or Hürthle cell cancer):
o minimally invasive FTC -which are considered low risk and are recommended by the specialist MDT based on overall clinico-pathological assessment
* pT1b and pT2: \>1-4cm intrathyroidal
* pT1a/1b/2/3a (where minimal microscopic ETE does not change the T score): any size up to 4 cm with minimal ETE if recommended by the MDT
* Histological material available for Central Review (see section 9.7)
* Willing to use contraception for the duration of the trial until 6 months post radioiodine treatment (for females) or 4 months post treatment (for males) (see section 6.4.2), if allocated to the ablation group.
Exclusion Criteria
* Up to 4cm non-invasive Encapsulated Follicular Variant of Papillary Thyroid Cancer (eFVPTC) with no capsular or vascular invasion (\>4 cm can be included at the discretion of the MDT)
* non-invasive follicular tumour with papillary-like nuclei (NIFTP)
* Anaplastic, poorly differentiated or medullary carcinoma
* R1 or R2 thyroidectomy
* Patients with:
* pN1b
* M1
* Aggressive Papillary thyroid cancer with any of the following features:
* Widely invasive
* Poorly differentiated
* Anaplastic
* Tall cell
* Columnar cell
* Diffuse sclerosing variants
* Follicular thyroid cancer/Hürthle cell cancer with any of the following features:
* Tumours greater than 4cm
* Widely invasive
* Poorly differentiated
* Anaplastic
* Incomplete resection or lobectomy
* pT4a and pT4b or macroscopic and microscopic tumour invasion of loco-regional tissues or structures
* Pregnant women or women who are breast feeding
* Patients who have had CT performed with iv contrast less than 2-3 months before ablation
* Previous treatment for thyroid cancer (except surgery in last 6 months)
* 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
* The following GI conditions: dysphagia, oesophageal stricture, active gastritis, gastric erosions, peptic ulcer, suspected reduced gastrointestinal motility
* MDT decision against ablation or suitability for trial in light of severe co-morbid condition/s 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
Eligibility Criteria using TNM8:
* pT1a - Papillary and Follicular carcinoma which is unifocal and ≤1cm in size, without any positive nodes or unfavourable clinical features, treated by lobectomy.
* Up to 4cm non-invasive Encapsulated Follicular Variant of Papillary Thyroid Cancer (eFVPTC) with no capsular or vascular invasion (\>4 cm can be included at the discretion of the MDT)
* non-invasive follicular tumour with papillary-like nuclei (NIFTP)
* Anaplastic, poorly differentiated or medullary carcinoma
* R1 or R2 thyroidectomy
* Patients with:
* pN1a with level VII involvement
* pN1b
* M1
* Aggressive Papillary thyroid cancer with any of the following features:
* Widely invasive
* Poorly differentiated
* Anaplastic
* Tall cell
* Columnar cell
* Diffuse sclerosing variants
* Follicular thyroid cancer/Hürthle cell cancer with any of the following features:
* Tumours greater than 4cm
* Widely invasive
* Poorly differentiated
* Anaplastic
* Incomplete resection or lobectomy
* pT3b, pT4a and pT4b or macroscopic and microscopic tumour invasion of loco-regional tissues or structures
* Pregnant women or women who are breast feeding
* Patients who have had CT performed with iv contrast less than 2-3 months before ablation
* Previous treatment for thyroid cancer (except surgery in last 6 months)
* 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
* The following GI conditions: dysphagia, oesophageal stricture, active gastritis, gastric erosions, peptic ulcer, suspected reduced gastrointestinal motility
* MDT decision against ablation or suitability for trial in light of severe co-morbid condition/s 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
16 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Ujjal Mallick, MBBS, Master of Surgery, FRCR
Role: PRINCIPAL_INVESTIGATOR
Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Locations
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, , United Kingdom
Mid Essex Hospitals Services NHS Trust
Chelmsford, , United Kingdom
Gloucestershire Hospitals NHS Trust
Cheltenham, , United Kingdom
Royal Derby hospital NHS foundation trust
Derby, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Royal Devon and Exeter NHS Trust
Exeter, , United Kingdom
Glasgow and Clyde NHS Trust
Glasgow, , United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, , United Kingdom
Ipswich Hospital NHS Trust
Ipswich, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough, , United Kingdom
Velindre NHS Trust
Nantgarw, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Norfolk and Norwich University Hospitals NHS Trust
Norwich, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Southend University Hospitals NHS Trust
Southend, , United Kingdom
East and North Herts
Stevenage, , United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Countries
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References
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Mallick U, Newbold K, Beasley M, Garcez K, Wadsley J, Johnson SJ, Stephenson T, Gaze M, Goodman A, Jefferies S, Sivabalasingham S, Slevin N, Wilkinson DP, Macias-Fernandez E, Power D, Roques T, Speed L, Nutting C, Mochloulis G, Gerrard G, Candish C, Morgan S, Tripathi D, Truran P, Arthur C, Wieczorek A, Madhavan K, Maclean J, Boote D, Kim D, Pascoe A, Pitiyage G, Forsyth S, Ambrose E, Chang E, Farnell K, Hackshaw A. Thyroidectomy with or without postoperative radioiodine for patients with low-risk differentiated thyroid cancer in the UK (IoN): a randomised, multicentre, non-inferiority trial. Lancet. 2025 Jul 5;406(10498):52-62. doi: 10.1016/S0140-6736(25)00629-4. Epub 2025 Jun 18.
Related Links
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Cancer Research UK \& UCL Cancer Trials Centre website
Other Identifiers
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2011-000144-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Cancer Research UK
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ISRCTN
Identifier Type: REGISTRY
Identifier Source: secondary_id
UCL/10/0299
Identifier Type: -
Identifier Source: org_study_id
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