Minimize Radioactive Iodine Ablation Of Remnant Thyroid i... | NCT02418247

Studies
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

NCT02418247

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jan 20, 2017Estimated

Enrollment

556Estimated

Phase

Phase 2Phase 3

Conditions

Thyroid Neoplasms

Interventions

I131
I123

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1410650-1,2	Other Grant/Funding Number	NCC Research Fund

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013Actual

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Apr 13, 2015

First Submission Date that Met QC Criteria

Apr 15, 2015

First Posted Date

Apr 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2017

Last Update Posted Date

Jan 20, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

556Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
low dose RAI	Active Comparator	Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.	Drug: I131
diagnostic RAI	Sham Comparator	Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.	Drug: I123

Interventions

Name	Type	Description	Arm Group Labels	Other Names
I131	Drug		low dose RAI	low dose RAI
I123

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biochemical Remission Rate		within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eun Kyung Lee, M.D.,Ph.D.	National Cancer Center, Korea	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungnam National University Hospital		Daejun			South Korea
National Cancer Center, Korea

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000614965	Iodine-131
C000614958	Iodine-123

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided