IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients

NCT01398085 | Active Not Recruiting Phase 2

• 4 other identifiers: UCL/10/02992011-000144-21Cancer Research UKISRCTN
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 36

Brief 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.

Conditions

Thyroid Cancer; Thyroid Neoplasms

Keywords

Papillary thyroid carcinoma; Follicular thyroid carcinoma; Hurthle cell carcinoma of the thyroid; Iodine Radioisotopes

Outcome Measures

Primary Outcomes (2)

• Phase II: monthly patient accrual rates

  To determine if recruitment into a phase III trial is feasible

  Evaluated within months 7-18 of the trial

• Phase III: Disease-free thyroid specific survival

  DFS measured from randomisation until date of recurrence or death from thyroid cancer

  From randomisation until recurrence or death from thyroid cancer

Secondary Outcomes (8)

• Phase III: Mortality (cause and date of death)

  From randomisation until death

• Phase III: Occurrence of loco-regional recurrence or metastatic disease

  After follow up is complete (estimated year 8-9 of trial)

• Phase III: Stage of cancer at the time of recurrence, and the ability to treat this successfully

  After follow up is complete (estimated year 8-9 of trial)

• Phase III: Health-related quality of life

  After follow up is complete (estimated year 8-9 of trial)

• Phase III: Adverse events for all patients

  After follow up is complete (estimated year 8-9 of trial)

Study Arms (2)

Radioactive iodine (RAI) ablation Arm

ACTIVE COMPARATOR

Patients will be randomised to receive Radioactive iodine (RAI) ablation I131 1.1 GBq

Radiation: I131 1.1 GBq

No Radioactive iodine (No-RAI) ablation

OTHER

Patients will be randomised to receive No Radioactive iodine (No-RAI) ablation

Other: No Radioactive iodine (No-RAI) ablation

Interventions

No Radioactive iodine (No-RAI) ablation OTHER

No Radioactive iodine (No-RAI) ablation

No Radioactive iodine (No-RAI) ablation

I131 1.1 GBq RADIATION

Radio-iodine

Also known as: Sodium iodide capsule

Radioactive iodine (RAI) ablation Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• pN1b
• 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:

Sponsors & Collaborators

• Cancer Research UK: collaborator
• University College, London: lead

Study Sites (36)

Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 5BE, United Kingdom

Location

University Hospital Bristol NHS Foundation Trust

Bristol, BS1 3NU, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

East Kent Hospitals University NHS Foundation Trust

Canterbury, CT1 3NG, United Kingdom

Location

Velindre NHS Trust

Cardiff, CF15 7QZ, United Kingdom

Location

Mid and South Essex NHS Foundation Trust

Chelmsford, United Kingdom

Location

Gloucestershire Hospitals NHS Trust

Cheltenham, United Kingdom

Location

Royal Derby Hospital NHS Foundation Trust

Derby, DE223NE, United Kingdom

Location

NHS Lothian

Edinburgh, EH4 2XU, United Kingdom

Location

Royal Devon and Exeter Hospital NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Glasgow and Clyde NHS Trust

Glasgow, G12 0YN, United Kingdom

Location

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU1 4JW, United Kingdom

Location

Hull University Teaching Hospitals NHS Trust

Hull, HU16 5JU, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, IP4 5PD, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Location

Maidstone and Tunbridge Wells NHS Trust

Maidstone, ME16 9QQ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

South Tees Hospitals NHS Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

University Hospitals Dorset NHS Foundation Trust

Poole, DT1 2JY, United Kingdom

Location

Portsmouth Hospitals University NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2SJ, United Kingdom

Location

Southend University Hospitals NHS Trust

Southend, SS0 0RY, United Kingdom

Location

East and North Hertfordshire NHS Trust

Stevenage, SG1 4AB, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40543520 DERIVED

Related Links

• Cancer Research UK \& UCL Cancer Trials Centre website

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid cancer, Hurthle cell

Interventions

Sodium Iodide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ujjal Mallick, MBBS MS FRCR

  Newcastle-upon-Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 20, 2011
• Study Start: June 26, 2012
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

GB (36)