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

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03747783
Collaborator
(none)
400
1
73.9
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radical Operation

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)

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Development and Validation of Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer: a Single-institutional Study
Actual Study Start Date :
Jan 3, 2013
Anticipated Primary Completion Date :
Jan 3, 2019
Anticipated Study Completion Date :
Mar 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Survival Group

status from radical operation to follow-up

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.

Non-Survival Group

status from radical operation to follow-up

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.

Outcome Measures

Primary Outcome Measures

  1. Overall survival [Follow up 5 year]

    time from laryngectomy to death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • laryngeal carcinoma patients with radical surgery
Exclusion Criteria:
  • multiple primarry malignant neo-plasms

Contacts and Locations

Locations

Site City State Country Postal Code
1 Genglong Liu Guangzhou State... China 510080

Sponsors and Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Xiaojun Tan, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GengLong Liu, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT03747783
Other Study ID Numbers:
  • Laryngeal cacer
First Posted:
Nov 20, 2018
Last Update Posted:
Nov 27, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GengLong Liu, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 27, 2018