Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

Phase 2

• Conditions: Thyroid Neoplasms
• Interventions: Drug: I131; Drug: I123

• Registration Number: NCT02418247
• Lead Sponsor: National Cancer Center, Korea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20
• Primary Completion: 2017-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 556

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose RAI	I131	Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
diagnostic RAI	I123	Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.

Primary Outcome Measures

Name	Time	Method
Biochemical Remission Rate	within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration

Trial Locations

Locations (5)

Chungnam National University Hospital; 🇰🇷 Daejun, Korea, Republic of

National Cancer Center, Korea; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Sungnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of