Selective Neck Dissection Versus Modified Neck Dissection in PTC

Phase 3Not Yet RecruitingNCT06554652

Fudan University250 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Thyroid Cancer

Interventions

Lymph node tracer navigated selective neck dissectionPROCEDURE

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).

Modified neck dissectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 14 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Local-regional Recurrence Rate，LRR

The percentage of patients with local-regional recurrence in the total number of patients.

Time frame: 5 years

Progression Free Survival，PFS

The time from surgery to tumor progression, including local-regional recurrence and distant metastasis.

Time frame: 5 years

Overall Survival，OS

The time from surgery to patient death

Time frame: 5 years

Adverse Events，AE

The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery.

Time frame: 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).

Time frame: 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.

Time frame: 5 years

Data from ClinicalTrials.gov

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