Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Iodine I 131 With or Without Thyroid-Stimulating Hormone in Treating Patients Who Have Undergone Surgery for Thyroid Cancer

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.

Eligibility: 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)

Relevance to patient case: not relevant