- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02604472
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
Status
Completed
Intervention / Treatment
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:
- firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;
- with complete medical records;
- received radical RT.
Exclusion Criteria:
- distant metastasis patients at first diagnosis,
- recurrent patients,
- 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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- 2013046
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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