Condition category
Cancer
Date applied
14/06/2006
Date assigned
11/09/2006
Last edited
11/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Medical School Administration
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22551128

Publication citations

Additional files

Editorial Notes

11/04/2016: Publication reference added.