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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
16/05/2012
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr Ujjal Mallick
Recruitment target:
570
EudraCT number:
2011-000144-21
Contact details:
ctc.ion@ucl.ac.uk
Lay summary:
IoN
Is ablative radiOiodine Necessary for low risk patients.
Description
Design: IoN is a randomised, non-blind, non-inferiority phase III multicentre trial, randomised using the minimisation method and stratified according to site, patient age, T Stage and N Stage to decide if patients will receive radioactive iodine ablation or not. 
Treatment: Radioactive Iodine (RAI) ablation using an activity of 1.1 GBq is given in one trial group and there is no ablation (No-RAI ablation) in the other group. All patients receive TSH suppression therapy (T3/4) after surgery as per routine practice. rhTSH will be given to patients in sites where it is standard practice. Patients receiving rhTSH do not need to undergo hormone withdrawal. 
Key inclusion/exclusion criteria: Patients with low risk differentiated thyroid cancer who have had a R0 total thyroidectomy within the last 6 months are eligible, dependant on all other inclusion criteria being met. Patients must not have pT1a (unifocal), pN1b or M1 staging or aggressive papillary thyroid cancer and cannot have had previous treatment for thyroid cancer, except surgery. 
Duration of recruitment: Anticipated recruitment will be 6-7 years with a minimum accrual of 454 patients. 
Aim
The overall aim is 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. This will be assessed by recording the rate of histologically confirmed structural loco-regional recurrent or residual disease and also distant recurrences. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
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Email:
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Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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