Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

NCT ID: NCT02418247

Last Updated: 2017-01-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Thyroid Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

I131

Intervention Type DRUG

diagnostic RAI

Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.

Group Type SHAM_COMPARATOR

I123

Intervention Type DRUG

Interventions

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I131

Intervention Type DRUG

I123

Intervention Type DRUG

Other Intervention Names

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low dose RAI diagnostic RAI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eun Kyung Lee

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

National Cancer Center, Korea

Goyang, , South Korea

Site Status

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Seoul National University Bundang Hospital

Sungnam, , South Korea

Site Status

Countries

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South Korea

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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