Malignant Neoplasm of Other Specified Site of NasopharynxNCT02604472
Retrospective Investigation of the Impacts of Prognosis for Nasopharyngeal Carcinoma Patients
An observational study of Malignant Neoplasm of Other Specified Site of Nasopharynx, run by Sun Yat-sen University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Neoplasm of Other Specified Site of Nasopharynx
- What is being tested?
- CCRT and IC+CCRT
- How many people
- 12,206 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013
Who may be able to join
- firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;
- with complete medical records;
- received radical RT.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- CCRT, IC+CCRT
- Keywords
- Nasopharyngeal carcinoma, induction chemotherapy, concurrent chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRTOther
Locoregionally advanced nasopharyngeal carcinoma patients received platinum-based/non-platinum based concurrent chemoradiotherapy.
IC+CCRTOther
Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and platinum-based/non-platinum based concurrent chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CCRT group | Locoregionally advanced nasopharyngeal carcinoma patients received concurrent chemoradiotherapy Receives: Other: CCRT | |
| IC+CCRT group | Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and concurrent chemoradiotherapy Receives: Other: IC+CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: up to 10 years
Secondary outcomes (1)
disease-free survival
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJan 1998
- Primary completionJun 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Other Specified Site of NasopharynxStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG YANQUN, Sun Yat-sen University
- Investigators
- Xiang Guo, MD, PhD, Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604472
- Sponsor's protocol ID
- 2013046
- Status last verified
- Nov 2015
- First submitted
- 11 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xia WX, Liang H, Lv X, Wang L, Ye YF, Ke LR, Xu LH, Guo X, Xiang YQ. Stage-specific concurrent chemoradiotherapy with or without induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a retrospective, population-based study. Cancer Manag Res. 2019 Nov 20;11:9813-9827. doi: 10.2147/CMAR.S179139. eCollection 2019.
PubMed 31819619
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage-specified Concurrent Chemoradiotherapy With or Without Induction Chemotherapy for Locoregionally-advanced Nasopharyngeal Carcinoma - A Retrospective, Population-based Study
- ClinicalTrials.gov ID
- NCT02604472
- Acronym / sponsor ID
- 2013046
- Keywords
- Nasopharyngeal carcinoma, induction chemotherapy, concurrent chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,206 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRT group | – | Other: CCRTLocoregionally advanced nasopharyngeal carcinoma patients received concurrent chemoradiotherapy |
| IC+CCRT group | – | Other: IC+CCRTLocoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and concurrent chemoradiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013
Key inclusion criteria (3 listed)
- firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;
- with complete medical records;
- received radical RT.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCRTLocoregionally advanced nasopharyngeal carcinoma patients received platinum-based/non-platinum based concurrent chemoradiotherapy. | Other | CCRT group |
| IC+CCRTLocoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and platinum-based/non-platinum based concurrent chemoradiotherapy. | Other | IC+CCRT group |
Primary outcome
overall survival
Time frame: up to 10 years
1 secondary outcome
disease-free survival
Time frame: up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Derived from this study: PubMed 31819619Xia WX, Liang H, Lv X, Wang L, Ye YF, Ke LR, Xu LH, Guo X, Xiang YQ. Stage-specific concurrent chemoradiotherapy with or without induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a retrospective, population-based study. Cancer Manag Res. 2019 Nov 20;11:9813-9827. doi: 10.2147/CMAR.S179139. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Guo, MD, PhD study chair
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Other Specified Site of Nasopharynx, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.