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A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Neck Dissection for cN0 Supraglottic Laryngeal Cancer

NCT03392220 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2018-01-09

No results posted yet for this study

Summary

Supraglottic laryngeal carcinoma patients with clinically negative neck (cN0) will be randomized divided into two groups. Patients in case group will undergo unilateral neck dissection (II-IV) while bilateral neck dissection (II-IV) in control group. Regional control rate is the primary endpoint and comparison will be made to see if unilateral dissection can get similar regional control as control group.

Conditions

  • Laryngeal Neoplasms
  • Malignant Neoplasm of Supraglottis Primary
  • Neck Dislocation

Interventions

PROCEDURE

Unilateral Neck Dissection

patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor

PROCEDURE

Bilateral Neck Dissection

patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Jilin Provincial Tumor Hospital

    collaborator OTHER

  • Jinzhou Medical University

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Xiaolei Wang, MD · Cancer Hospital Chinese Academy of Medical Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2020-09-30
Completion
2022-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03392220 on ClinicalTrials.gov