Selective Neck Dissection Versus Modified Neck Dissection in PTC

Phase 3

Not yet recruiting

• Conditions: Thyroid Cancer
• Interventions: Procedure: Modified neck dissection; Procedure: Lymph node tracer navigated selective neck dissection

• Registration Number: NCT06554652
• Lead Sponsor: Fudan University

Brief Summary

This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-27
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Study Start: 2024-09-01
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Pathologically confirmed PTC;
• Age range: 14-80 years old;
• Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
• Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and <1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
• Thyroid tumors without extra thyroidal extension;
• Enough thyroid volume to inject tracer.

Exclusion Criteria

• Previous neck surgery;
• Bilateral neck lymph node dissection;
• Distant metastases;
• High risk pathological subtypes or the presence of other high-risk factors for recurrence;
• Previous treatment for thyroid cancer other than endocrine therapy;
• The patient is unable to cooperate with follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified neck dissection	Modified neck dissection	-
Selective neck dissection	Lymph node tracer navigated selective neck dissection	-

Primary Outcome Measures

Name	Time	Method
Local-regional Recurrence Free Survival，LRFS	5 years	The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival，PFS	5 years	The time from surgery to tumor progression, including local-regional recurrence and distant metastasis.
Adverse Events，AE	5 years	The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery.
Local-regional Recurrence Rate，LRR	5 years	The percentage of patients with local-regional recurrence in the total number of patients.
Quality of Life as assessed by QoL/Thyroid	5 years	Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Thyroid Cancer Quality of Life Scale QoL/Thyroid.
Overall Survival，OS	5 years	The time from surgery to patient death
Quality of Life as assessed by UW-QOL V4.1	5 years	Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Washington University Quality of Life Questionnaire V4.1 (UW-QOL V4.1).

Trial Locations

Locations (1)

Fudan Univeristy Shanghai Cancer Center; 🇨🇳 Shanghai, China