Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Pablo Alvarez
ORCID ID
Contact details
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
-
pa@ctc.ucl.ac.uk
Additional identifiers
EudraCT number
2005-003687-37
ClinicalTrials.gov number
NCT00415233
Protocol/serial number
BRD/05/83
Study information
Scientific title
Multicentre randomised trial of High dose versus Low dose radioiodine, with or without recombinant human thyroid stimulating hormone, for remnant ablation following surgery for differentiated thyroid cancer
Acronym
HiLo
Study hypothesis
1. To examine whether a low administrative dose (1.1 GBq) of radioiodine has a similar remnant ablation success rate as a high dose (3.7 GBq)
2. To examine whether patients given recombinant human Thyroid Stimulating Hormone (rhTSH) have a similar ablation success rate to those who discontinue thyroid hormone replacement
Ethics approval
Cambridgeshire 4 Research Ethics Committee, 14/07/2006, ref: 06/MRE05/39
Study design
Factorial randomised trial (a trial of equivalence)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Differentiated thyroid cancer
Intervention
Following surgery, eligible patients will be approached for consent. Those who agree will be randomised to one of the following groups:
Group A: rhTSH followed by 1.1 GBq of radioiodine ablation
Group B: rhTSH followed by 3.7 GBq of radioiodine ablation
Group C: Hormone withdrawal (i.e., no rhTSH) followed by 1.1 GBq of radioiodine ablation
Group D: Hormone withdrawal (i.e., no rhTSH) followed by 3.7 GBq of radioiodine ablation
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
The percentage of patients who have a successful remnant ablation six to eight months after radioiodine administration
Secondary outcome measures
1. Quality of life during treatment period
2. Loco-regional recurrence
3. Distant metastases
Long term outcomes:
1. Survival and incidence of secondary primary malignancies
Overall trial start date
01/09/2006
Overall trial end date
01/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histological confirmation of differentiated thyroid carcinoma
2. Patients with tumour stage pT1-T3; NX, N0 or N1; M0 (TNM Classification of Malignant Tumours 6th edition 2002)
3. Patients who have undergone total thyroidectomy with or without lymph node dissection
4. Patients who require radioiodine ablation
5. Aged 16 to 80 years
6. World Health Organization (WHO) performance status zero to two (self caring)
7. All known tumour resected (R0)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
468
Participant exclusion criteria
1. Hurthle cell carcinoma and aggressive variants including tall cell, insular, poorly differentiated, diffuse sclerosing and widely invasive subtypes; anaplastic and medullary carcinoma
2. Patients who have a contrast Computed Tomography (CT) scan up to three months before ablation
3. Patients for whom rhTSH requirement is mandatory
4. Patients who have severe co-morbid conditions (e.g., 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. Other cancers excluding basal cell carcinoma of the skin or in situ carcinoma of the cervix
6. Pregnant women or women who are breastfeeding
7. Patients with stage pT4 or M1 (if detected clinically or by other investigations)
8. Previous 131I or 123I pre-ablation scan
9. Previous treatment for thyroid cancer (except surgery)
Recruitment start date
01/01/2007
Recruitment end date
31/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK & UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom
Funders
Funder type
Research organisation
Funder name
Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22551128