Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

National Cancer Center (NCC)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Thyroid Neoplasms

Treatments: Drug: I123; Drug: I131

Study type: Interventional

Funder types: Other

Identifiers

NCT02418247

NCCCTS13-671

1410650-1,2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 556 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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556 participants in 2 patient groups

low dose RAI

Active Comparator group

Description:

Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.

Treatment:

Drug: I131

diagnostic RAI

Sham Comparator group

Description:

Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.

Treatment:

Drug: I123