Selective Neck Dissection Versus Modified Neck Dissection in PTC

Tracer Navigated Selective Neck Dissection Versus Modified Neck Dissection in Papillary Thyroid Cancer With Limited Lymph Node Metastasis in the Lateral Neck: A Randomized, Noninferiority Phase III Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: Lymph node tracer navigated selective neck dissection; Procedure: Modified neck dissection

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yu Wang, Dr.; Phone Number: 65805 86-021-64175590; Email: neck130@sina.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan Univeristy Shanghai Cancer Center
    • Contact: Yu Wang, M.D.; Phone Number: 65805 86-021-64175590; Email: neck130@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective neck dissection	Procedure: Lymph node tracer navigated selective neck dissection; Selective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected).
Active Comparator: Modified neck dissection	Procedure: Modified neck dissection; Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local-regional Recurrence Free Survival，LRFS	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local-regional Recurrence Rate，LRR	The percentage of patients with local-regional recurrence in the total number of patients.	5 years
Progression Free Survival，PFS	The time from surgery to tumor progression, including local-regional recurrence and distant metastasis.	5 years
Overall Survival，OS	The time from surgery to patient death	5 years
Adverse Events，AE	The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery.	5 years
Quality of Life as assessed by UW-QOL V4.1	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).	5 years
Quality of Life as assessed by QoL/Thyroid	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.	5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: SELECTION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No