Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

NCT02418247 — Phase 2 / Phase 3, Unknown, 556 participants, National Cancer Center, Korea
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Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients

RegistryNCT02418247
StatusUnknown
PhasePhase 2 / Phase 3
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment556 (Estimated)
SponsorNational Cancer Center, Korea (Other gov)
ConditionsThyroid Neoplasms
InterventionsI131, I123 (Drug)
Datesstart 2013-05-01, primary completion 2017-12-01 (estimated), completion 2020-12-01 (estimated), first posted 2015-04-16, last updated 2017-01-20
Locations5 sites in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Thyroid Neoplasms All trials of I131 All trials of I123

-Summary

The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.

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+Arms and interventions

ArmTypeInterventionsDescription
low dose RAIActive comparatorDrug: I131Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
diagnostic RAISham comparatorDrug: I123Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
  • I131 (Drug), also known as low dose RAI
  • I123 (Drug), also known as diagnostic RAI

+Outcome measures

Primary outcomes

  • Biochemical Remission Rate [within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration]

+Eligibility

Sex: All, ages: 18 Years to 79 Years

Inclusion Criteria:

* patients with differentiated thyroid cancer
* recently underwent total thyroidectomy (within 6 months)
* pathological criteria

  1. T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci)
  2. T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle)
  3. T1-3N1a : 3 or less micrometastatic lymph node

Exclusion Criteria:

* differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer
* gross extension (strap muscle or more)
* thyroid cancer with distant metastasis
* previous remote history of thyroid cancer surgery
* history of cervical external beam radiation therapy
* previous history of comorbid cancer within 5 years
* renal insufficiency (Ccr <30ml/min)
* women with pregnancy or breast feeding

+Locations (5)

FacilityCityCountryStatus
Chungnam National University HospitalDaejunSouth Korea
National Cancer Center, KoreaGoyangSouth Korea
Seoul National University Boramae Medical CenterSeoulSouth Korea
Seoul National University HospitalSeoulSouth Korea
Seoul National University Bundang HospitalSungnamSouth Korea

+Investigators