Nomograms to Precisely Predict Conditional Risk of Recurrence for Patients With Laryngeal Cancer

NCT ID: NCT03595410

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-01-01

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.

Detailed Description

Demographic, clinical, and survival data were abstracted. Death was verified via medical records and the social security death index. Primary outcome measures were OS (time from salvage laryngectomy to death from any cause), disease-specific survival (DSS; time from salvage laryngectomy to death from recurrent/persistent laryngeal SCC), and DFS (time from salvage laryngectomy to laryngeal SCC recurrence)

Conditions

Recurrent Laryngeal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Recurrence laryngeal cancer

Recurrence laryngeal cancer

Intervention Type: OTHER

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

No recurrence laryngeal cancer

Recurrence laryngeal cancer

Intervention Type: OTHER

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

Interventions

Recurrence laryngeal cancer

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

patients with a diagnosis of laryngeal squamous cell carcinoma

Exclusion Criteria

multiple primarry malignant neo-plasms

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

GengLong Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Genglong Liu

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Genglong Liu

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Genglong Liu, MD

Role: CONTACT

lglong3@mail2.sysu.edu.cn

+8615626405844

Facility Contacts

Genglong Liu, MD

Role: primary

lglong3@mail2.sysu.edu.cn

+8615626405844

Other Identifiers

Laryngeal carcinoma

Identifier Type: -

Identifier Source: org_study_id