High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Biological: recombinant thyroid-stimulating hormoneRadiation: Radiodine ablation without rhTSH
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 438
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 3.2 GBq with rhTSH recombinant thyroid-stimulating hormone Patients receive 3.2GBq dose of radioactive idodine and rhTSH 1.1GBq without rhTSH Radiodine ablation without rhTSH Patients only receive 1.1GBq dose of radioactive iodine and no rhTSH 1.1Gbq with rhTSH recombinant thyroid-stimulating hormone Patients receive 1.1GBq dose of radioactive iodine and rhTSH 3.2GBq without rhTSH Radiodine ablation without rhTSH Patients only receive 3.2GBq dose of radioactive iodine and no rhTSH
- 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)
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Wales, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke-On-Trent, England, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, England, United Kingdom