Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

Thyroid Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02418247
• Other study ID #: NCCCTS13-671
• Secondary ID: 1410650-1,2
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 13, 2015
• Last updated: January 18, 2017
• Start date: May 2013
• Est. completion date: December 2020

Study information

• Verified date: January 2017
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 556
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• I131

• I123

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejun
Korea, Republic of	National Cancer Center, Korea	Goyang
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Remission Rate		within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration