NCT05604963招募中不适用
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 456
- 试验地点
- 33
- 主要终点
- 3 Year Recurrence Rate
研究概览
简要总结
This is a multi-centre, randomised, non-inferiority, phase III study in patients with low risk differentiated thyroid cancer.
Patients will be identified via oncology multidisciplinary team meetings. There will be two sources of patients in the trial, with the same histological diagnoses and prognosis (i.e. recurrence risk):
- Group 1: Patients who have already had a HT for thyroid problems and are then subsequently diagnosed with low risk DTC will be randomised 1:1 to undergo surveillance only OR a second operation to remove the rest of their thyroid gland (two-stage total thyroidectomy).
- Group 2: Patients diagnosed with low risk DTC using cytology (Thy5) but no surgery performed will be randomised 1:1 to have either a hemi-thyroidectomy OR a single-stage total thyroidectomy.
The overall aim of the trial is to determine whether hemithyroidectomy is an acceptable and cost-effective surgical procedure compared to total thyroidectomy in low risk thyroid cancer. Overall, 456 patients will be recruited to the trial. Patients will be initially be followed up post-surgery then 12 monthly for 6 years.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1 (HT already performed prior to diagnosis)
- •Inclusion criteria
- •Aged 16 or over
- •Papillary thyroid cancer:
- •pT1b-2 (≤4cm) irrespective of molecular genetic markers
- •R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local MDT)
- •cN0 or pN0, pNX & pN1a (≤5 foci, no extranodal spread)
- •Confined to thyroid or minimal extrathyroidal extension
- •No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)
- •No angioinvasion NB. PTC is still eligible where microscopic invasion of endothelial lined small capillary vascular spaces and lymphatic channels are present. It becomes ineligible in the rare instances when there is definite invasion of a larger vascular structure such as a vein with smooth muscle in its wall.
- •Encapsulated FVPTC with capsular invasion only
- •Micro-PTC (≤1cm)
- •multifocal
- •unifocal with pN1a (≤5 foci; no extranodal spread)
- •Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:
- •pT1b-2 (≤4cm) irrespective of molecular genetic markers
- •- Minimally invasive, with capsular invasion +/- minimal (≤4 foci) vascular invasion (the latter is now called encapsulated angioinvasive and is at the discretion of the MDT)
- •Confined to thyroid or minimal extrathyroidal extension
排除标准
- •unifocal pT1a (≤1cm) PTC or FTC (unless pN1a as above)
- •NIFTP (non-invasive follicular thyroid neoplasm with papillary-like nuclear features)
- •Anaplastic, poorly differentiated or medullary thyroid carcinoma
- •gross extrathyroidal extension
- •pT4 or macroscopic tumour invasion of loco-regional tissues or structures
- •pN1a with >5 foci or extranodal spread
- •Aggressive PTC with any of the following features:
- •Widely invasive
- •Poorly differentiated
- •Anaplastic
- •predominance of Tall cell, Columnar cell, Hobnail, Diffuse sclerosing and other higher risk variants
- •FTC, including oncocytic or Hürthle cell cancer with any of the following features:
- •Minimally invasive with extensive vascular invasion (now called encapsulated angioinvasive) (>4 foci)
- •Widely invasive
- •Poorly differentiated
- •Anaplastic
- •Group 2 (DTC on cytology or after core biopsy, who has not had prior thyroid surgery yet)
- •Inclusion criteria
- •Aged 16 or over
- •'low risk' differentiated thyroid cancer confirmed by cytology or core biopsy.
- •cT1b-2 irrespective of molecular genetic markers
- •Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)
- •Exclusion criteria
研究组 & 干预措施
Group 1: Two-stage Completion Thyroidectomy
Active Comparator
Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
干预措施: Total Thyroidectomy (Procedure)
Group 1: Surveillance
No Intervention
Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.
Group 2: Hemi-thyroidectomy
Experimental
Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.
干预措施: Hemithyroidectomy (Procedure)
Group 2: Total Thyroidectomy
Active Comparator
Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.
干预措施: Total Thyroidectomy (Procedure)
结局指标
主要结局
3 Year Recurrence Rate
时间窗: From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date
(defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
次要结局
- Anatomical Site of Recurrence(From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date)
- Risk of Loco-Regional Recurrence(From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date)
- Secondary Care Health Resource Use(a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery)
- Primary Care Health Resource Use(a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery)
- Number of Additional Investigations and Procedures after Surgery(2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery)
- Type of Additional Investigations and Procedures after Surgery(2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery)
- Voice Function(Surgical complications and severity: From surgery date to discharge, 2-4 weeks, 6 months and 18 months from date of surgery; Voice Function: Post-randomisation/pre-surgery, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- Requirement for Hormone Replacement Therapy(From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- Surgical complications and severity(Surgical complications and severity: From surgery date to discharge, 2-4 weeks, 6 months and 18 months from date of surgery; Voice Function: Post-randomisation/pre-surgery, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- 5 Year Recurrence Rate(From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 5 years from surgery date)
- Health Related Quality of Life (EORTC QLQ-C30)(Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- Health Related Quality of Life (EORTC QLQ-THY35)(Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- Health Related Quality of Life (EQ-5D-5L)(Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- Health Related Quality of Life (FoP-Q-SF)(Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.)
- Cost and Health Resource Use (EQ-5D-5L)(a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery)
- Cost and Health Resource Use (EORTC QLQ-C30)(a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery)
- Cost and Health Resource Use (EORTC QLQ-THY34)(a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery)
研究者
研究点 (33)
Loading locations...
相似试验
进行中（未招募）
不适用
HoT – A phase III randomised trial to compare the rates of cancer returning in patients with low-risk differentiated thyroid cancer after a hemithyroidectomy and total thyroidectomyCancerISRCTN17004671niversity College London456
进行中（未招募）
3 期
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT TrialNCT04513717NRG Oncology2,753
招募中
3 期
Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-upIntermediate RiskThyroid CancerNCT04290663Centre Francois Baclesse368
已完成
1 期
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac SurgeryAtrial FibrillationNCT00289367Northwell Health280
Unknown
不适用
Randomized Investigation of Thyroid Operation as Day SurgeryHemithyroidectomyOutpatientHemmorhageNCT02891252Zealand University Hospital86