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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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. MallickPrincipal Investigator

Jonathan A. LedermannStudy Director

Dymphna LeePh: 020 7679 9392
  Email: ion@ctc.ucl.ac.uk

Trial Sites

United Kingdom
  Birmingham
 University Hospitals Birmingham NHS Foundation Trust
 Hisham MehannaPrincipal Investigator
  Bristol
 University Hospitals Bristol NHS Foundation Trust
 Matthew BeasleyPrincipal Investigator
  Cambridge
 Addenbrooke's Hospital
 Sarah JefferiesPrincipal Investigator
  Chelmsford
 Mid Essex Hospitals Services NHS Trust
 Abdel HamidPrincipal Investigator
  Cheltenham
 Gloucestershire Hospitals NHS Trust
 Charles CandishPrincipal Investigator
  Dorset
 Dorset Cancer Centre
 Perric CrellinPrincipal Investigator
  Edinburgh
 Lothian NHS
 Mark StrachanPrincipal Investigator
  Exeter
 Royal Devon and Exeter Hospital
 Andy GoodmanPrincipal Investigator
  Glasgow
 Greater Glasgow and Clyde NHS Board
 Nicholas S. ReedPrincipal Investigator
  Ipswich
 Ipswich Hospital
 Christopher ScrasePrincipal Investigator
  Kent
 Kent and Canterbury Hospital
 Elena MaciasPrincipal Investigator
  Leeds
 Leeds Cancer Centre at St. James's University Hospital
 Georgina GerrardPrincipal Investigator
  Leicester
 University Hospitals of Leicester NHS Trust
 Irene PeatPrincipal Investigator
  London
 Charing Cross Hospital
 Danielle PowerPrincipal Investigator
 Guys and St Thomas' NHS Foundation Trust
 Hosahalli MohanPrincipal Investigator
 Royal Marsden - Surrey
 Kate NewboldPrincipal Investigator
 University College London Hospitals NHS Foundation Trust
 Mark GazePrincipal Investigator
  Maidstone
 Maidstone Hospital
 Nick RowellPrincipal Investigator
  Manchester
 Christie Hospital
 Beng YapPrincipal Investigator
  Middlesbrough
 James Cook University Hospital
 John HardmanPrincipal Investigator
  Nant Garw
 Velindre NHS Trust
 Laura MossPrincipal Investigator
  Newcastle
 Newcastle Upon Tyne Hospitals NHS Trust
 Ujjal MallickPrincipal Investigator
  Norwich
 Norfolk and Norwich University Hospitals NHS Trust
 Tom RoquesPrincipal Investigator
  Nottingham
 Nottingham City Hospital
 Sally MorganPrincipal Investigator
  Portsmouth
 Portsmouth Hospitals NHS Trust
 Dae KimPrincipal Investigator
  Sheffield
 Cancer Research Centre at Weston Park Hospital
 Jon WadsleyPrincipal Investigator
  Southend
 Southend University Hospitals NHS Trust
 Krishnaswamy MadhavanPrincipal Investigator
  Surrey
 St. Luke's Cancer Centre at Royal Surrey County Hospital
 Stephen WhitakerPrincipal Investigator
  Wolverhampton
 Royal Wolverhampton NHS Trust
 Laura PetittPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01398085
ClinicalTrials.gov processed this data on October 14, 2014

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.

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