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

ISRCTN	ISRCTN56078540
DOI	https://doi.org/10.1186/ISRCTN56078540
ClinicalTrials.gov (NCT)	NCT00415233
Clinical Trials Information System (CTIS)	2005-003687-37
Protocol serial number	BRD/05/83
Sponsor	University College London (UK)
Funder	Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)

Submission date: 14/06/2006
Registration date: 11/09/2006
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-radioactive-iodine-treatment-for-thyroid-cancer

Contact information

Mr Pablo Alvarez
Scientific

Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Email	pa@ctc.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Factorial randomised trial (a trial of equivalence)
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	HiLo
Study objectives	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(s)	Cambridgeshire 4 Research Ethics Committee, 14/07/2006, ref: 06/MRE05/39
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The percentage of patients who have a successful remnant ablation six to eight months after radioiodine administration
Key secondary outcome measure(s)	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
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	468
Key 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)
Key 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)
Date of first enrolment	01/01/2007
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cancer Research UK & UCL Cancer Trials Centre

London
W1T 4TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
11/04/2016: Publication reference added.