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

NCT ID: NCT03747783

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-03
• Study Completion Date: 2019-03-03

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.However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study,the investigators 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

Laryngeal Cancer

Study Design

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

Study Groups

Survival Group

status from radical operation to follow-up

Radical Operation

Intervention Type: PROCEDURE

The surgery treatment selection was based on the American Joint Committee on Cancer stage both of the primary and of the recurrence, as well as on patterns of local spread that were not included in the T classification and on the general condition and preferences of each patient.

Non-Survival Group

status from radical operation to follow-up

Radical Operation

Intervention Type: PROCEDURE

The surgery treatment selection was based on the American Joint Committee on Cancer stage both of the primary and of the recurrence, as well as on patterns of local spread that were not included in the T classification and on the general condition and preferences of each patient.

Interventions

Radical Operation

The surgery treatment selection was based on the American Joint Committee on Cancer stage both of the primary and of the recurrence, as well as on patterns of local spread that were not included in the T classification and on the general condition and preferences of each patient.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• laryngeal carcinoma patients with radical surgery

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

Xiaojun Tan

Role: STUDY_CHAIR

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Locations

Genglong Liu

Guangzhou, State..., China

Site Status: RECRUITING

Countries

China

Central Contacts

Genglong Liu

Role: CONTACT

lglong3@mail2.sysu.edu.cn

+8615626405844

Facility Contacts

Genglong Liu

Role: primary

lglong3@mail2.sysu.edu.cn

+8615626405844

Other Identifiers

Laryngeal cacer

Identifier Type: -

Identifier Source: org_study_id