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]
16 Years
80 Years
Both
Head and Neck Cancer
Trial Information
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]
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed differentiated thyroid cancer
- T1-T3, Nx, N0, N1, M0 disease
- Has undergone one- or two-stage total thyroidectomy with or without lymph node
dissection
- All known tumor resected (R0)
- Requires radioiodine remnant ablation
- Does not require mandatory recombinant thyroid-stimulating hormone
- No Hurthle cell carcinoma or aggressive variants, including any of the following:
- Tall cell, insular, poorly differentiated disease with diffuse sclerosing
- Anaplastic or medullary carcinoma
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No severe comorbid conditions including, but not limited to, any of the following:
- Unstable angina
- Recent heart attack or stroke
- Severe labile hypertension
- Dementia
- Concurrent dialysis
- Tracheostomy needing care
- Learning difficulties
- Inability to comply with radiation protection issues
- Requirement for frequent nursing or medical supervision that puts staff at risk
for unacceptable radiation exposure
- No other cancers except basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception during and for 6 months
after radioiodine remnant ablation
- Fertile male patients must use effective contraception during and for 4 months after
radioiodine remnant ablation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior contrast CT scan
- No prior iodine I 131 or iodine I 123 pre-ablation scan
- No prior treatment for thyroid cancer (except surgery)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of patients with successful remnant ablation at 6-9 months
Outcome Description:
The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.
Outcome Time Frame:
6-9 months
Safety Issue:
No
Principal Investigator
Ujjal K. Mallick, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Newcastle-upon-Tyne Hospitals NHS Trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CDR0000522490
NCT ID:
NCT00415233
Start Date:
November 2006
Completion Date:
June 2015
Related Keywords:
- Head and Neck Cancer
- stage I follicular thyroid cancer
- stage I papillary thyroid cancer
- stage II follicular thyroid cancer
- stage II papillary thyroid cancer
- stage III follicular thyroid cancer
- stage III papillary thyroid cancer
- stage IV follicular thyroid cancer
- stage IV papillary thyroid cancer
- Thyroid Neoplasms
- Head and Neck Neoplasms
- Thyroid Diseases
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