Retrospective Investigation of the Impacts of Prognosis for Nasopharyngeal Carcinoma Patients

Completed

• Conditions: Malignant Neoplasm of Other Specified Site of Nasopharynx
• Interventions: Other: CCRT; Other: IC+CCRT

• Registration Number: NCT02604472
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1998-01
• Primary Completion: 2013-06
• Study Completion: 2015-10
• Status Verified: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-12
• Last Update Submitted: 2015-11-12
• Study First Posted: 2015-11-13
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12206

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCRT group	CCRT	Locoregionally advanced nasopharyngeal carcinoma patients received concurrent chemoradiotherapy
IC+CCRT group	IC+CCRT	Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and concurrent chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
overall survival	up to 10 years

Secondary Outcome Measures

Name	Time	Method
disease-free survival	up to 10 years