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A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol

Endocrinology and Metabolism 2020년 35권 3호 p.571 ~ 577
이은경, 이유진, 박영주, 문재훈, 이가희, 김군순, 이주희, 조선욱, 주정남, 황보율, 고수정, 박도준,
소속 상세정보
이은경 ( Lee Eun-Kyung ) - National Cancer Center Center for Thyroid Cancer
이유진 ( Lee You-Jin ) - National Cancer Center Center for Thyroid Cancer
박영주 ( Park Young-Joo ) - Seoul National University Hospital Department of Internal Medicine
문재훈 ( Moon Jae-Hoon ) - Seoul National University Bundang Hospital Department of Internal Medicine
이가희 ( Yi Ka-Hee ) - Seoul Metropolitan Government-Seoul National University Boramae Medical Center Department of Internal Medicine
김군순 ( Kim Koon-Soon ) - Chungnam National University College of Medicine Department of Internal Medicine
이주희 ( Lee Joo-Hee ) - Chungnam National University College of Medicine Department of Internal Medicine
조선욱 ( Cho Sun-Wook ) - Seoul National University Hospital Department of Internal Medicine
주정남 ( Joo Jung-Nam ) - National Cancer Center Cancer Biostatistics Branch
황보율 ( Hwangbo Yul ) - National Cancer Center Center for Thyroid Cancer
고수정 ( Go Su-Jeong ) - National Cancer Center Center for Thyroid Cancer
박도준 ( Park Do-Joon ) - Seoul National University Hospital Department of Internal Medicine

Abstract


Background
Radioactive iodine (RAI) remnant ablation is recommended in patients with papillary thyroid cancer (PTC) and extrathyroidal extension or central lymph node metastasis. However, there exists little evidence about the necessity of remnant ablation in PTC patients with low- to intermediate-risk, those have been increasing in recent decades.

Methods
This multicenter, prospective, non-randomized, parallel group clinical trial will enroll 310 eligible patients with low- to intermediate-risk of thyroid cancer. Inclusion criteria are patients who recently underwent total thyroidectomy for PTC with 3 or less tumors of size 1≤ to ≤2 cm with no microscopic extension and N0/x, or size ≤2 cm with microscopic extension and/or N1a (number of lymph node ≤3, size of tumor foci ≤0.2 cm, and lymph node ratio <0.4). Patients choose to undergo RAI ablation (131I, dose 1.1 GBq) or diagnostic whole-body scan (DxWBS) (131I or 123I, dose 0.074 to 0.222 GBq), followed by subsequent measurement of stimulated thyroglobulin (sTg) within 1 year. Survey for quality of life (QOL) will be performed at baseline and at 1 year after follow-up. The total enrollment period is 5 years, and patients will be followed up for 1 year. The primary endpoint is the non-inferiority of surgery alone to surgery with ablation in terms of biochemical remission (BCR) rate (sTg ≤2 ng/mL) without evidence of structural recurrence. The secondary endpoint was the difference of QOL.

Conclusion
This study will evaluate whether surgery alone achieves similar BCR and improved QOL compared to RAI ablation in patients with low- to intermediate-risk PTC within 1 year.

키워드

Iodine-131; Quality of life; Thyroid cancer, papillary; Prospective studies

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