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NCT Number: NCT06554652

Selective Neck Dissection Versus Modified Neck Dissection in PTC

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.

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Key information

Conditions

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

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

Location status: Recruiting

Location contact

Yu Wang, M.D.

CONTACT

[email protected]

86-021-64175590 ext. 65805

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

modified neck dissection

Procedure

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

Primary outcomes

  1. Local-regional Recurrence Free Survival，LRFS

    Time frame: 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 outcomes

  1. Local-regional Recurrence Rate，LRR

    Time frame: 5 years

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

  2. Progression Free Survival，PFS

    Time frame: 5 years

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

  3. Overall Survival，OS

    Time frame: 5 years

    The time from surgery to patient death

  4. Adverse Events，AE

    Time frame: 5 years

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

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

    Time frame: 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).

  6. Quality of Life as assessed by QoL/Thyroid

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Wang, Dr.

CONTACT

[email protected]

86-021-64175590 ext. 65805

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 15, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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