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 |
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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
Contact information
Mr Pablo Alvarez
Scientific
Scientific
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
pa@ctc.ucl.ac.uk |
Study information
Study design | Factorial randomised trial (a trial of equivalence) |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2006 |
Completion date | 01/09/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Cancer Research UK & UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom
W1T 4TJ
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Medical School Administration
Gower Street
London
WC1E 6BT
England
United Kingdom
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.