NCT03595410

Brief Summary

Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies Program Laryngeal Cancer Trial and subsequent studies demonstrated similar overall survival (OS) rates for organ preservation protocols involving radiotherapy (RT) or chemoradiotherapy (CRT) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. As such, the use of RT or CRT has become the predominant initial intervention for patients with laryngeal SCC.6 However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study, we sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal SCC in order to set patient expectations and address modifiable risk factors. Identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. Herein,we examine a cohort of patients with recurrent or persistent laryngeal SCC after definitive RT/CRT who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

July 13, 2018

Last Update Submit

July 13, 2018

Conditions

Keywords

risk of recurrenceNomogramsLaryngeal cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    time from salvage laryngectomy to death from any cause

    Follow up 5 years

Study Arms (2)

Recurrence laryngeal cancer

Other: Recurrence laryngeal cancer

No recurrence laryngeal cancer

Other: Recurrence laryngeal cancer

Interventions

Recurrence laryngeal cancer has a wide range of invasion, rapid progression and poor prognosis.

No recurrence laryngeal cancerRecurrence laryngeal cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with laryngeal cancer

You may qualify if:

  • patients with a diagnosis of laryngeal squamous cell carcinoma

You may not qualify if:

  • multiple primarry malignant neo-plasms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genglong Liu

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Genglong Liu

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 23, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations