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

Phase 3

Active, not recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT00415233
• Lead Sponsor: University College, London

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.

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-22
• Primary Completion: 2011-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-19
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with successful remnant ablation at 6-9 months	6-9 months	The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months	Baseline to 3 months	Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months
Locoregional recurrence	During and post treatment
Distant metastases	Baseline to 5 years after randomisation of final patient	After the 5 year follow up period, patients will be follwed at hospital according to routine practice.
Survival	Until patient death
Incidence of second primary malignancy	Baseline to 5 years after last patient is randomised	After the 5 year follow up period, patients will be follwed at hospital according to routine practice.

Trial Locations

Locations (25)

Sussex Cancer Centre at Royal Sussex County Hospital; 🇬🇧 Brighton, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Kent and Canterbury Hospital; 🇬🇧 Canterbury, England, United Kingdom

Castle Hill Hospital; 🇬🇧 Cottingham, England, United Kingdom

Derbyshire Royal Infirmary; 🇬🇧 Derby, England, United Kingdom

Royal Devon and Exeter Hospital; 🇬🇧 Exeter, England, United Kingdom

Gloucestershire Royal Hospital; 🇬🇧 Gloucester, England, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital; 🇬🇧 Guildford, England, United Kingdom

Ipswich Hospital; 🇬🇧 Ipswich, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

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