Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
NCT ID: NCT02418247
Last Updated: 2017-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
556 participants
INTERVENTIONAL
2013-05-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low dose RAI
Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
I131
diagnostic RAI
Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
I123
Interventions
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I131
I123
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Eun Kyung Lee
M.D., Ph.D.
Principal Investigators
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Eun Kyung Lee, M.D.,Ph.D.
Role: STUDY_CHAIR
National Cancer Center, Korea
Locations
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Chungnam National University Hospital
Daejun, , South Korea
National Cancer Center, Korea
Goyang, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
Sungnam, , South Korea
Countries
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Other Identifiers
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1410650-1,2
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCCCTS13-671
Identifier Type: -
Identifier Source: org_study_id
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