Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients
2 other identifiers
interventional
556
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 20, 2017
January 1, 2017
4.6 years
April 13, 2015
January 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical Remission Rate
within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
Study Arms (2)
low dose RAI
ACTIVE COMPARATORLow dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
diagnostic RAI
SHAM COMPARATORDiagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eun Kyung Lee, M.D.,Ph.D.
National Cancer Center, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 16, 2015
Study Start
May 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2020
Last Updated
January 20, 2017
Record last verified: 2017-01