Nasopharyngeal CarcinomaNCT04387266
To Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC
An observational study of Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- modified reduce-volume target IMRT
- Type of treatment
- Surgery or procedure
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Oct 2020
- 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: Non-metastatic NPC patients treated with modified reduce-volume target IMRT in our institution
Who may be able to join
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- Newly diagnosed, non-metastatic and treated with modified reduce-volume IMRT;
- Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
- Diagnosis time: November 1, 2014 to December 31 , 2017
Who cannot join
- Disease progression during IMRT;
- Previous malignancy or other concomitant malignant diseases;
- The evaluation information of tumor efficacy can not be obtained;
- Receive blind treatment in other clinical research.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, 350014
About this study
Official title: A Retrospective Real-world Study in Patients With Nasopharyngeal Carcinoma: to Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC
This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- modified reduce-volume target IMRT
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified reduce-volume target IMRTRadiation
The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Modified reduce-volume target IMRT | Patients with newly diagnosed, non-metastatic NPC was given modified reduce-volume target IMRT Receives: Radiation: modified reduce-volume target IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure-free survival (LFFS)
The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure.
Measured: 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jun 2020
- Primary completion1 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387266
- Sponsor's protocol ID
- NPC004
- Status last verified
- Oct 2020
- First submitted
- 10 May 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Real-world Study in Patients With Nasopharyngeal Carcinoma: to Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC
- ClinicalTrials.gov ID
- NCT04387266
- Acronym / sponsor ID
- NPC004
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 13 May 2020 (actual)
- 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.
This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified reduce-volume target IMRT | – | Radiation: modified reduce-volume target IMRTPatients with newly diagnosed, non-metastatic NPC was given modified reduce-volume target IMRT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-metastatic NPC patients treated with modified reduce-volume target IMRT in our institution
Key inclusion criteria (4 listed)
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- Newly diagnosed, non-metastatic and treated with modified reduce-volume IMRT;
- Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
- Diagnosis time: November 1, 2014 to December 31 , 2017
Key exclusion criteria (4 listed)
- Disease progression during IMRT;
- Previous malignancy or other concomitant malignant diseases;
- The evaluation information of tumor efficacy can not be obtained;
- Receive blind treatment in other clinical research.
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 |
|---|---|---|
| modified reduce-volume target IMRTThe gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively. | Radiation | Modified reduce-volume target IMRT |
Primary outcome
Local failure-free survival (LFFS)
Time frame: 60 month
The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure.
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 9 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
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 4 inclusion and 4 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 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Local failure-free survival (LFFS) (time frame: 60 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2020.