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

NCT03747783 | Unknown

• 1 other identifier: Laryngeal cacer
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Cancer

Keywords

Survival; Nomograms; Laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  time from laryngectomy to death from any cause

  Follow up 5 year

Study Arms (2)

Survival Group

status from radical operation to follow-up

Procedure: Radical Operation

Non-Survival Group

status from radical operation to follow-up

Procedure: Radical Operation

Interventions

Radical Operation 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; Survival Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

laryngeal carcinoma patients with radical surgery

You may qualify if:

• laryngeal carcinoma patients with radical surgery

You may not qualify if:

• multiple primarry malignant neo-plasms

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Genglong Liu

Guangzhou, State..., 510080, China

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Xiaojun Tan

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Genglong Liu

CONTACT

+8615626405844; lglong3@mail2.sysu.edu.cn

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: November 17, 2018
• First Posted: November 20, 2018
• Study Start: January 3, 2013
• Primary Completion: January 3, 2019
• Study Completion: March 3, 2019
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

CN (1)