Back to resultsMinimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
Primary Purpose
Thyroid Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
I131
I123
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Neoplasms focused on measuring radioactive iodine therapy, ablation, thyroid cancer
Eligibility Criteria
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
Sites / Locations
- Chungnam National University Hospital
- National Cancer Center, Korea
- Seoul National University Boramae Medical Center
- Seoul National University Hospital
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
low dose RAI
diagnostic RAI
Arm Description
Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
Outcomes
Primary Outcome Measures
Biochemical Remission Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02418247
First Posted
April 13, 2015
Last Updated
January 18, 2017
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02418247
Brief Title
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
Official Title
Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms
Keywords
radioactive iodine therapy, ablation, thyroid cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
556 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose RAI
Arm Type
Active Comparator
Arm Description
Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.
Arm Title
diagnostic RAI
Arm Type
Sham Comparator
Arm Description
Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.
Intervention Type
Drug
Intervention Name(s)
I131
Other Intervention Name(s)
low dose RAI
Intervention Type
Drug
Intervention Name(s)
I123
Other Intervention Name(s)
diagnostic RAI
Primary Outcome Measure Information:
Title
Biochemical Remission Rate
Time Frame
within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Kyung Lee, M.D.,Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejun
Country
Korea, Republic of
Facility Name
National Cancer Center, Korea
City
Goyang
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
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