- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418247
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
January 18, 2017 updated by: Eun Kyung Lee, National Cancer Center, Korea
Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
556
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Daejun, Korea, Republic of
- Chungnam National University Hospital
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Goyang, Korea, Republic of
- National Cancer Center, Korea
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Seoul National University Boramae Medical Center
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Sungnam, Korea, Republic of
- Seoul National University Bundang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with differentiated thyroid cancer
- recently underwent total thyroidectomy (within 6 months)
pathological criteria
- T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci)
- T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle)
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: low dose RAI
Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
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Other Names:
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Sham Comparator: diagnostic RAI
Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biochemical Remission Rate
Time Frame: within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
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within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Eun Kyung Lee, M.D.,Ph.D., National Cancer Center, Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2013
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
April 13, 2015
First Submitted That Met QC Criteria
April 15, 2015
First Posted (Estimate)
April 16, 2015
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCCTS13-671
- 1410650-1,2 (Other Grant/Funding Number: NCC Research Fund)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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