Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer

NCT03358602 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2017-12-12

No results posted yet for this study

Summary

Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic cancer. Current management, following the US National Comprehensive Cancer Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. The investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.

Conditions

  • Supraglottic Cancer

Interventions

RADIATION

Radiotherapy

Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes

PROCEDURE

Selective neck dissection

Selective neck dissection, defined as surgical clearance of the upper jugular (leveI II), midjugular (level III) and sometimes submandibular (level I) nodes, is used to manage the cervical lymph nodes

Sponsors & Collaborators

  • Tianjin Medical University General Hospital

    collaborator OTHER
  • Tianjin Medical University Second Hospital

    collaborator OTHER
  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Lun Zhang, Ph.D · Tianjin Medical University Cancer Institute and Hospital

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
2017-12-20
Primary Completion
2025-11-01
Completion
2027-11-01

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 NCT03358602 on ClinicalTrials.gov