HiLo: Multicentre randomised phase III clinical trial of high versus low dose radioiodine, with or without recombinant human thyroid stimulating hormone (rhTSH), for remnant ablation following surgery for differentiated thyroid cancer - HiLo

• Conditions: Differentiated thyroid cancer (DTC)

• Registration Number: EUCTR2005-003687-37-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age 16-80 years
2.Patients who have undergone one or two-stage total thyroidectomy with or without lymph node dissection.
3.Patients with histological confirmation of differentiated thyroid cancer (including Hurthle cell carcinoma) who require radioiodine ablation.
4.Patient with tumour stage pT1-T3; NX, N0 or N1
5.WHO performance status 0-2 (self caring)
6.All known tumour resected (R0)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Aggressive variants including tall cell, insular, poorly differentiated, diffuse sclerosing and widely invasive subtypes; anaplastic and medullary carcinoma.
2.Patients who have a contrast CT scan up to 3 months before ablation.
3.Patients for whom recombinant human TSH requirement is mandatory.
4.Patients who have severe co-morbid conditions (eg unstable angina, recent heart attack or stroke, severe labile hypertension, dementia, on dialysis, with tracheostomy needing care, learning difficulties and anybody who may not be able to comply with radiation protection issues or need frequent nursing/medical supervision which puts staff at risk of unacceptable radiation exposure)
5.Pregnant women or women who are breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified