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

Basic Trial Information

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)

• pT1b (1-2cm), intrathyroidal

• pT2 (2-4cm), intrathyroidal

• pT3, intrathyroidal only

• Multifocal microcarcinoma

• pN0

• pN1a

• pNX

• Follicular thyroid cancer/ Hürthle cell cancer (minimally invasive with capsular invasion only)

• pT1b (1- 2cm), 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

• angio invasive

• 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

Ujjal K. Mallick

Principal Investigator

Jonathan A. Ledermann

Study Director

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

United Kingdom
	Bristol
	University Hospitals Bristol NHS Foundation Trust
		Matthew Beasley	Principal Investigator
	Kent
	Kent and Canterbury Hospital
		Elena Macias	Principal Investigator
	London
	Royal Marsden - Surrey
		Kate Newbold	Principal Investigator
	Newcastle
	Newcastle Upon Tyne Hospitals NHS Trust
		Ujjal Mallick	Principal Investigator
	Surrey
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Stephen Whitaker	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01398085
Information obtained from ClinicalTrials.gov on November 20, 2012

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