Selective Neck Dissection Versus Modified Neck Dissection in PTC

NCT06554652 | Recruiting Phase 3

• 1 other identifier: SELECTION
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Local-regional Recurrence Rate，LRR

  5 years

• Progression Free Survival，PFS

  5 years

• Overall Survival，OS

  5 years

• Adverse Events，AE

  5 years

• Quality of Life as assessed by UW-QOL V4.1

  5 years

Study Arms (2)

Selective neck dissection

EXPERIMENTAL

Procedure: Lymph node tracer navigated selective neck dissection

Modified neck dissection

ACTIVE COMPARATOR

Procedure: Modified neck dissection

Interventions

Lymph node tracer navigated selective neck dissection PROCEDURE

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).

Selective neck dissection

Modified neck dissection PROCEDURE

Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.

Modified neck dissection

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Yu Wang, Dr.

CONTACT

86-021-64175590; neck130@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 15, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)