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

Status

Unknown

Conditions

Intervention / Treatment

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

  • Korea, Republic of
      • Daejun, Korea, Republic of
        • Chungnam National University Hospital
      • Goyang, Korea, Republic of
        • National Cancer Center, Korea
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Boramae Medical Center
      • Sungnam, Korea, Republic of
        • Seoul National University Bundang Hospital

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

    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

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

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
within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

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

Keywords

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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