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

University College, London438 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Conditions

Head and Neck Cancer

Interventions

recombinant thyroid-stimulating hormoneBIOLOGICAL

Recombinant thyroid stimulating hormone (rhTSH) should be given at a dose of 0.9mg by intramuscular injection on two consecutive days before ablation.

Radiodine ablation without rhTSHRADIATION

Patients in this group do not receive rhTSH pre ablation.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (25)

Outcomes

Primary Outcomes

Proportion of patients with successful remnant ablation at 6-9 months

The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.

Time frame: 6-9 months

Secondary Outcomes

Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months

Time frame: Baseline to 3 months

Locoregional recurrence

Time frame: During and post treatment

Distant metastases

After the 5 year follow up period, patients will be follwed at hospital according to routine practice.

Time frame: Baseline to 5 years after randomisation of final patient

Survival

Time frame: Until patient death

Incidence of second primary malignancy

After the 5 year follow up period, patients will be follwed at hospital according to routine practice.

Time frame: Baseline to 5 years after last patient is randomised

Data from ClinicalTrials.gov

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