Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2006-12-20
Brief Title:
High Dose vs Low Dose I 131 - rhTSH for Differentiated Thyroid Cancer
Sponsor:
University College London
Organization:
University College London
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HiLo
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-003687-37 | EUDRACT_NUMBER | Regulatory Authority Number | None |
| CRUK-HILO-BRD0583 | OTHER_GRANT | None | None |
| ISRCTN56078540 | REGISTRY | None | None |
| EU-20665 | None | None | None |
| CTA-2036302170010001 | OTHER | None | None |