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

Laryngeal Cancer Clinical Trial

Official title:

Development and Validation of Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer: a Single-institutional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03747783
• Other study ID #: Laryngeal cacer
• Status: Recruiting
• Start date: January 3, 2013
• Est. completion date: March 3, 2019

Study information

• Verified date: November 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Genglong Liu
• Phone: +8615626405844
• Email: lglong3[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• laryngeal carcinoma patients with radical surgery

Exclusion Criteria:

• multiple primarry malignant neo-plasms

Related Conditions & MeSH terms

• Laryngeal Cancer
• Laryngeal Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Genglong Liu	Guangzhou	State...

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	time from laryngectomy to death from any cause	Follow up 5 year