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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 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
- •INCLUSION CRITERIA:
- •Patients must have histologically or cytologically confirmed at least 1 thyroid nodule that is greater than or equal to1 cm. but less than or equal to 4 cm measured in greatest dimension and confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) or confirmed by the pathology laboratory of the enrolling institution:
- •Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with B-Raf Proto-oncogene Serine/Threonine Kinase (BRAF) Valine 600 Glutamic Acid (V600E) mutation or rearranged in transformation/papillary thyroid carcinomas (RET/PTC) rearrangement
- •Cytologically or histologically suspicious or confirmed PTC per Bethesda System for reporting thyroid cytopathology.
- •Age greater than or equal to 18 years. Because PTC occurs rarely in patients <18 years of age, children are excluded from this study.
- •Absence of radiographic evidence of extrathyroidal extension.
- •Absence of abnormal lymphadenopathy suggesting metastatic PTC on physical examination and/or imaging studies.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •Patients must have adequate organ function to safely undergo general anesthesia and thyroidectomy. Laboratory values obtained less than or equal to 4 weeks prior to surgery must demonstrate adequate bone marrow function (hemoglobin (Hb) greater than or equal to 6.0 mmol/L, absolute neutrophil count greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 80 x 10^9/L), liver function (serum bilirubin less than or equal to 2 x upper limit of normal (ULN), serum transaminases less than or equal to 3 x ULN). Patients with chronic kidney disease who are on chronic renal replacement therapy are allowed. Other tests, such as pulmonary function tests, cardiac echocardiogram or stress test, will be performed if clinically indicated.
- •Ability of subject to understand and the willingness to sign a written informed consent document.
- •Women must not become pregnant prior to surgery or during the first 3 months after surgery. Women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery.
排除标准
- •Patients who have had previous thyroid surgery
- •Patients whose tumors are deemed unresectable by clinical/imaging criteria.
- •Patients with known synchronous distant metastatic disease.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded because we do not want to expose the unborn child to the procedures necessary to perform the surgery.
研究组 & 干预措施
Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND)
Active Comparator
TT plus pCND
干预措施: Total Thyroidectomy (TT) (Procedure)
Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND)
Active Comparator
TT plus pCND
干预措施: Prophylactic central neck lymph node dissection (pCND) (Procedure)
Arm 1/Total Thyroidectomy (TT) alone
Active Comparator
TT alone
干预措施: Total Thyroidectomy (TT) (Procedure)
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 (1)
Loading locations...
相似试验
招募中
2 期
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid CarcinomaSurgeryRecurrenceThyroid CancerNCT06087068Cancer Institute and Hospital, Chinese Academy of Medical Sciences140
招募中
3 期
A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid CancerThyroid CancerRecurrenceNCT06082180Cancer Institute and Hospital, Chinese Academy of Medical Sciences1,199
招募中
不适用
Function Integrity of Neck Anatomy in Thyroid SurgeryRetina AblationThyroid Nodule (Benign)Thyroid CarcinomaNCT04666103Wuhan University1,264
已完成
3 期
rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)Differentiated Thyroid CancerNCT04964284Suzhou Zelgen Biopharmaceuticals Co.,Ltd390
进行中（未招募）
不适用
To Study the Impact of Radiation Treatment After Surgery in Patient With Locally Advanced Thyroid Cancer.Thyroid Cancer Stage IVRadiation ToxicityNCT03669432Tata Memorial Hospital72