NCT02408887终止2 期
Randomized Controlled Trial of Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in Patients With Low-risk Papillary Thyroid Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)
研究概览
简要总结
Background:
- Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea.
Objective:
- To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid.
Eligibility:
- Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body.
Design:
- Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays.
- Participants will:
- Answer questions. They may have a tumor biopsy.
- Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords.
- Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread.
- Group 2: have surgery to remove the thyroid and lymph nodes in the neck.
- At all post-surgery visits, participants will answer questions and have blood drawn. In addition:
- 1 day: laryngoscopy.
- 2 weeks: possible laryngoscopy.
- 3 months: ultrasound of the thyroid and neck.
- Discuss whether to try hormone treatment and/or radioactive iodine.
- Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a capsule or liquid and lie under a camera.
- 6 months: ultrasound and maybe laryngoscopy.
- 1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone.
- Participants will have annual follow-up visits for 10 years. They will have a physical exam, blood drawn, scans, and may complete a questionnaire.
详细描述
Background:
- Thyroid cancer is the most common endocrine malignancy and papillary thyroid cancer (PTC) accounts for more than 80% of thyroid cancer.
- The incidence of thyroid cancer has risen over the past decades.
- Central neck lymph node metastasis (LNM) is common in PTC and preoperative imaging studies do not identify all involved lymph nodes in the central neck.
- It remains controversial if prophylactic central neck lymph node dissection (pCND) in patients with low-risk PTC results in lower rates of persistent/recurrent disease and higher complication rates as there has been no randomized controlled trial addressing these issues to date.
- Serum thyroglobulin (Tg), especially when thyroid stimulating hormone (TSH)-stimulated, is a very sensitive and specific marker for persistent/recurrent PTC, in the absence of interfering anti-Tg antibodies.
- Retrospective studies have compared the postoperative TSH-stimulated Tg levels between those who underwent prophylactic central neck dissection (pCND) and those who did not with conflicting results. A randomized trial is needed.
- Health-related quality of life (QOL) is a well-accepted tool to measure the outcome of cancer treatments. Short-form 36 (SF-36) version 2 (v2) questionnaire has been frequently used to evaluate the QOL in patients with thyroid cancer. There is no study evaluating the difference in QOL in patients with low-risk PTC undergoing total thyroidectomy (TT) with and without pCND.
Objectives:
-To determine and compare biochemical cure rates in patients with low-risk PTCs undergoing total thyroidectomy (TT) with and without pCND as measured by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 3 months (prior to radioactive iodine treatment (RAI) treatment).
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)
时间窗: At 3 months (prior to radioactive iodine (RAI) treatment)
number of participants that have biochemical cure after total thyroidectomy (TT) with and without pCND as measured by postoperative thyroid stimulating hormone (TSH)-stimulated serum thyroglobulin (stim-Tg). Per protocol, Biochemical cure is defined as "stim-Tg \< 2 ng/ml or unstimulated Tg ≤ 0.2 ng/ml" post-surgery. Biochemical persistent or recurrent disease is suspected when stim-Tg ≥5 ng/ml or unstimulated Tg \>0.3 ng/ml or a conversion or a rise in anti-Tg antibodies.
次要结局
- B-Raf Proto-oncogene Serine/Threonine Kinase (BRAF) Valine 600 Glutamic Acid (V600E) Mutation Status on Lymph Node Metastasis(At progression)
- Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)(Up to 1 year postoperatively or 1 year post remnant ablation.)
- Voice Quality After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months(baseline - pre-op and 6 months post-op)
- Improvement in Swallowing Impairment After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months(baseline - pre-op and 6 months post-op)
- Number of Participants Who Developed Disease Progression or Recurrence After Surgery(Completed at pre-operation (op), 3 months, 6 months, 1 year, 2 years and 3 years post-op.)
- Number of Participants With Hypoparathyroidism(6 months)
- Number of Participants Who Completed Quality of Life (QOL) Survey at Following Timepoints: Quality of Life After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)(pre-operation(op), post-op day 1 and 2, 2 and 3 weeks post-op, 3, 6 and 9 months post-op, 1 and 2 years post-op. Approximately 4 years.)
- Number of Participants That Have Cervical Wound Complications(3 months)
- Proportion of Participants That Have Less Neck Pain.(6 months)
研究者
Naris Nilubol, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (2)
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