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 [HILO]
- Compare the percentage of successful remnant ablation at 6-8 months after
administration of high- vs low-dose iodine I 131 with vs without recombinant
thyroid-stimulating hormone in patients who have undergone total thyroidectomy for
differentiated thyroid cancer.
- Compare quality of life in patients treated with these regimens.
- Compare locoregional recurrence in patients treated with these regimens.
- Compare distant metastases, survival, and incidence of second primary malignancies in
patients treated with these regimens.
OUTLINE: This is a multicenter, factorial, randomized study. Patients are stratified
according to treatment center and disease stage (I vs II vs III vs IVA). Patients are
randomized to 1 of 4 treatment arms.
Patients receive thyroid hormone replacement therapy (THRT)* with thyroxine (T4)** or
liothyronine sodium (T3). Patients randomized to arm III or IV discontinue THRT 4 weeks (for
patients receiving T4) or 2 weeks (for patients receiving T3) prior to remnant ablation.
NOTE: *Some treatment centers may chose to avoid starting THRT in patients randomized to arm
III or IV.
NOTE: **Patients receiving T4 may be switched to T3 for 2 more weeks before discontinuing
- Arm I: Patients receive recombinant thyroid-stimulating hormone (rTSH) intramuscularly
on days 1 and 2 and undergo remnant ablation with low-dose iodine I 131 on day 3.
- Arm II: Patients receive rTSH as in arm I and undergo remnant ablation with high-dose
iodine I 131 on day 3.
- Arm III: Patients undergo remnant ablation with low-dose iodine I 131 as in arm I.
- Arm IV: Patients undergo remnant ablation with high-dose iodine I 131 as in arm II.
Quality of life is assessed at baseline, day 3 before remnant ablation, and at 3 months.
After completion of study therapy, patients are followed at 3 months, between 6-8 months,
and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 468 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Proportion of patients with successful remnant ablation at 6-9 months
The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.
Ujjal K. Mallick, MD
Newcastle-upon-Tyne Hospitals NHS Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency