Retrospective Investigation of the Impacts of Prognosis for Nasopharyngeal Carcinoma Patients

November 12, 2015 updated by: XIANG YANQUN, Sun Yat-sen University

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

12206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CCRT group
Locoregionally advanced nasopharyngeal carcinoma patients received concurrent chemoradiotherapy
Locoregionally advanced nasopharyngeal carcinoma patients received platinum-based/non-platinum based concurrent chemoradiotherapy.
IC+CCRT group
Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and concurrent chemoradiotherapy
Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and platinum-based/non-platinum based concurrent chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to 10 years
up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: up to 10 years
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Xiang Guo, MD, PhD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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