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
EudraCT/CTIS number 2005-003687-37
ClinicalTrials.gov number NCT00415233
Secondary identifying numbers BRD/05/83
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

Study designFactorial randomised trial (a trial of equivalence)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMulticentre 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 acronymHiLo
Study objectives1. 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) studiedDifferentiated thyroid cancer
InterventionFollowing 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 typeMixed
Primary outcome measureThe percentage of patients who have a successful remnant ablation six to eight months after radioiodine administration
Secondary outcome measures1. 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 study start date01/09/2006
Completion date01/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants468
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2007
Date of final enrolment31/07/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cancer Research UK & UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom

Sponsor information

University College London (UK)
University/education

Medical School Administration
Gower Street
London
WC1E 6BT
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Research organisation

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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