Retrospective Investigation of the Impacts of Prognosis for Nasopharyngeal Carcinoma Patients

Malignant Neoplasm of Other Specified Site of Nasopharynx Clinical Trial

Official title:

Stage-specified Concurrent Chemoradiotherapy With or Without Induction Chemotherapy for Locoregionally-advanced Nasopharyngeal Carcinoma - A Retrospective, Population-based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604472
• Other study ID #: 2013046
• Status: Completed
• Phase: N/A
• First received: November 11, 2015
• Last updated: November 12, 2015
• Start date: January 1998
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To investigate whether the additional induction chemotherapy (IC) to concurrent chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for locoregionally advanced NPC.

Description:

Data of patients firstly diagnosed NPC from Jan 1st, 1998 to Jun 1st, 2013 were downloaded from Department of Medical Information, Sun Yat-Sen University Cancer Center. Patients were excluded if they had stage I or II disease, no complete medical records, received treatment previously, or without concurrent chemoradiotherapy. Follow-up data is updated on October 1st, 2015.The propensity score-matching (PSM) method was adopted to balance observed covariates between both groups. Propensity scores reflect the conditional probability that is intended to be uniform between patients received CCRT and IC+CCRT based on their baseline characteristics. Matching was performed based on nearest-neighbor matching, and comparing between CCRT and IC+CCRT patients were matched within their respective risk groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12206
• Est. completion date: October 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;

2. with complete medical records;

3. received radical RT.

Exclusion Criteria:

1. distant metastasis patients at first diagnosis,

2. recurrent patients,

3. not finishing radiotherapy, missing medical data, death during RT, stage I or II disease,received treatment previously, or without concurrent chemoradiotherapy were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Malignant Neoplasm of Other Specified Site of Nasopharynx
• Nasopharyngeal Neoplasms
• Neoplasms

Intervention

Other:
• CCRT
Locoregionally advanced nasopharyngeal carcinoma patients received platinum-based/non-platinum based concurrent chemoradiotherapy.
• IC+CCRT
Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and platinum-based/non-platinum based concurrent chemoradiotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		up to 10 years	No
Secondary	disease-free survival		up to 10 years	No