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Levothyroxine Sodium Liquid Gel Capsules or Tablets in Treating Patients with Stage I-II Differentiated Thyroid Cancer after Surgery

Trial Status: Active

This phase IV trial studies how well levothyroxine sodium liquid gel capsules work compared to tablets in treating patients with stage I-II differentiated thyroid cancer after surgery. Hormone replacement therapy, such as levothyroxine sodium, may help control thyroid cancer in patients after surgery. It is not yet known whether giving levothyroxine sodium tablets or liquid gel capsules may work better in treating patients with thyroid cancer after surgery.

Inclusion Criteria

  • Differentiated thyroid cancer
  • Presumed American Joint Committee on Cancer (AJCC) tumor stage I or II
  • Planned total, near-total or completion thyroidectomy requiring lifelong thyroid hormone replacement
  • Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
  • Normal serum TSH within 12 months preceding surgery
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

  • AJCC stage III/IV differentiated thyroid cancer
  • Undifferentiated, anaplastic or medullary thyroid cancer
  • Planned postoperative TSH goal different than 0.1-0.5 mU/L
  • History of gastrointestinal mal-absorption or gastric bypass surgery
  • Pregnancy
  • Use of medications that alter the absorption or metabolism of levothyroxine
  • Prior use of levothyroxine
  • Anticipated ribonuclease inhibitor (RAI) treatment within 18 weeks of treatment

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Alex Tessnow
Phone: 214-645-2868

PRIMARY OBJECTIVES:

I. To compare the use of levothyroxine in liquid gel capsules to tablet form for thyroid stimulating hormone (TSH) suppression (target 0.1-0.5 MIU/L) following thyroidectomy for presumed stage I/II differentiated thyroid cancer.

SECONDARY OBJECTIVES:

I. To quantify the mean number of dose adjustments, and compare the two study agent group outcomes.

II. To assess and compare quality of life differences between study groups using scores on Thyroid version Quality of Life Questionnaire (QoL-Thyroid) and Underactive Thyroid Treatment Satisfaction Questionnaire (ThyTSQ) surveys.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive levothyroxine sodium liquid gel capsules orally (PO) once daily (QD) for 18 weeks in the absence of disease progression or unaccepted toxicity.

GROUP II: Patients receive levothyroxine sodium tablets PO QD for 18 weeks in the absence of disease progression or unaccepted toxicity.

After completion of study treatment, patients are followed up periodically.

Trial Phase Phase IV

Trial Type Treatment

Lead Organization
UT Southwestern / Simmons Cancer Center-Dallas

Principal Investigator
Alex Tessnow

  • Primary ID SCCC-03315; STU 022015-044
  • Secondary IDs NCI-2017-01363
  • Clinicaltrials.gov ID NCT02946918