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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IITreatmentActive16 and overOtherUCL/10/0299
2011-000144-21, Cancer Research UK, ISRCTN, NCT01398085

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University College Hospital - London

  • Cancer Research UK
Ujjal K. Mallick, Principal Investigator
Jonathan A. Ledermann, Study Director
Dymphna Lee
Ph: 020 7679 9392
Email: ion@ctc.ucl.ac.uk

Trial Sites

United Kingdom

Birmingham

University Hospitals Birmingham NHS Foundation Trust

Hisham Mehanna
Principal Investigator

Bristol

University Hospitals Bristol NHS Foundation Trust

Matthew Beasley
Principal Investigator

Cambridge

Addenbrooke's Hospital

Sarah Jefferies
Principal Investigator

Chelmsford

Mid Essex Hospitals Services NHS Trust

Abdel Hamid
Principal Investigator

Cheltenham

Gloucestershire Hospitals NHS Trust

Charles Candish
Principal Investigator

Dorset

Dorset Cancer Centre

Perric Crellin
Principal Investigator

Edinburgh

Lothian NHS

Mark Strachan
Principal Investigator

Exeter

Royal Devon and Exeter Hospital

Andy Goodman
Principal Investigator

Glasgow

Greater Glasgow and Clyde NHS Board

Nicholas S. Reed
Principal Investigator

Ipswich

Ipswich Hospital

Christopher Scrase
Principal Investigator

Kent

Kent and Canterbury Hospital

Elena Macias
Principal Investigator

Leeds

Leeds Cancer Centre at St. James's University Hospital

Georgina Gerrard
Principal Investigator

Leicester

University Hospitals of Leicester NHS Trust

Irene Peat
Principal Investigator

London

Charing Cross Hospital

Danielle Power
Principal Investigator

Guys and St Thomas' NHS Foundation Trust

Hosahalli Mohan
Principal Investigator

Royal Marsden - Surrey

Kate Newbold
Principal Investigator

University College London Hospitals NHS Foundation Trust

Mark Gaze
Principal Investigator

Maidstone

Maidstone Hospital

Nick Rowell
Principal Investigator

Manchester

Christie Hospital

Beng Yap
Principal Investigator

Middlesbrough

James Cook University Hospital

John Hardman
Principal Investigator

Nant Garw

Velindre NHS Trust

Laura Moss
Principal Investigator

Newcastle

Newcastle Upon Tyne Hospitals NHS Trust

Ujjal Mallick
Principal Investigator

Norwich

Norfolk and Norwich University Hospitals NHS Trust

Tom Roques
Principal Investigator

Nottingham

Nottingham City Hospital

Sally Morgan
Principal Investigator

Portsmouth

Portsmouth Hospitals NHS Trust

Dae Kim
Principal Investigator

Sheffield

Cancer Research Centre at Weston Park Hospital

Jon Wadsley
Principal Investigator

Southend

Southend University Hospitals NHS Trust

Krishnaswamy Madhavan
Principal Investigator

Surrey

St. Luke's Cancer Centre at Royal Surrey County Hospital

Stephen Whitaker
Principal Investigator

Wolverhampton

Royal Wolverhampton NHS Trust

Laura Petitt
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01398085
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.