NCT03358602

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Dec 2017Nov 2027

First Submitted

Initial submission to the registry

November 21, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

7.9 years

First QC Date

November 21, 2017

Last Update Submit

December 10, 2017

Conditions

Supraglottic Cancer

Keywords

Supraglottic cancerLaryngeal cancerCervical lymph nodeNeck dissection

Outcome Measures

Primary Outcomes (1)

  • Neck control rates

    The percentage of patients without cervical lymph node metastasis

    2 years

Secondary Outcomes (9)

  • Disease-free survival

    1 year

  • Disease-free survival

    2 years

  • Disease-free survival

    3 years

  • Disease-free survival

    5 years

  • Overall survival

    3 years

  • +4 more secondary outcomes

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Radiotherapy \& open partial supraglottic laryngectomy(primary tumor)

Radiation: Radiotherapy

Elective neck dissection

ACTIVE COMPARATOR

Elective neck dissection \& open partial supraglottic laryngectomy(primary tumor)

Procedure: Selective neck dissection

Interventions

RadiotherapyRADIATION

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

Radiotherapy
Selective neck dissectionPROCEDURE

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

Elective neck dissection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document
  • Age≥ 18 and≤ 75 years
  • Histological/ cytological/ Imaging examination proven supraglottic squamous-cell carcinoma in preoperative assessment
  • Cervical node negative according to the imaging characteristics and the physical examination
  • KPS≥ 70
  • Normal bone marrow reserve function and normal liver, kidney function
  • Expected survival period≥ 12 months

You may not qualify if:

  • Inability to provide an informed consent
  • Proved distant metastasis
  • Clinical stage 3-4
  • The patient has received prior surgery or radiotherapy (except for biopsy )
  • The patient has received chemotherapy(including targeted therapies) or immunotherapy
  • Prior malignancy within the previous 5 years
  • Severe mental disorders
  • Pregnant or lactating women
  • Other disease requiring simultaneous surgery or radiotherapy
  • Researchers believe that the situation is unsuitable for participation in the group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hopital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lun Zhang, Ph.D

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Xu Wang, Ph.D

CONTACT

+86 022 23340123wxd.1133@163.com

Ze Zhang, MD

CONTACT

+86 022 23340123zhangze_smu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 30, 2017

Study Start

December 20, 2017

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2027

Last Updated

December 12, 2017

Record last verified: 2017-11

Locations

CN(1)