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22 May 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | NCT00415233 |
| Public 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 |
| Scientific title | |
| Acronym | HiLo |
| Serial number at source | BRD/05/83 |
| 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 |
| Lay summary | http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-radioactive-iodine-treatment-for-thyroid-cancer |
| Ethics approval | Ethics approval received from the Cambridgeshire 4 Research Ethics Committee on the 14th July 2006 (ref: 06/MRE05/39). |
| Study design | Factorial randomised trial (a trial of equivalence). |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Differentiated thyroid cancer |
| Participants - 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) |
| Participants - 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) |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/09/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 468 |
| Interventions |
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 |
| Primary outcome measure(s) | The percentage of patients who have a successful remnant ablation six to eight months after radioiodine administration. |
| 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 |
| Sources of funding | Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) |
| Trial website | |
| Publications | |
| Contact name | Mr Pablo Alvarez |
| Address |
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road |
| City/town | London |
| Zip/Postcode | W1T 4TJ |
| Country | United Kingdom |
| pa@ctc.ucl.ac.uk | |
| Sponsor | University College London (UK) |
| Address |
Medical School Administration
Gower Street |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| Date applied | 14/06/2006 |
| Last edited | 09/05/2012 |
| Date ISRCTN assigned | 11/09/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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