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High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer — HiLo  

Head and Neck Cancer Clinical Trial

Official 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 [HILO]

Clinical Trial Summary

RATIONALE: Radioactive iodine uses radiation to kill tumor cells. Giving iodine I 131 with or without thyroid-stimulating hormone after surgery may kill any tumor cells that remain after surgery. It is not yet known which dose of iodine I 131 is more effective when given with or without thyroid-stimulating hormone in treating thyroid cancer. PURPOSE: This randomized phase III trial is studying two different doses of iodine I 131 to compare how well they work when given with or without thyroid-stimulating hormone in treating patients who have undergone surgery for thyroid cancer.

Clinical Trial Description

OBJECTIVES: Primary - 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. Secondary - 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 THRT. - 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00415233
Study type Interventional
Source University College, London
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 2006
Completion date July 2025
View Details
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