Nasopharynx CancerNCT03791944
3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma
A study testing 3DV+TPS/VARIAN, TPS / VARIAN and 3DV + TPS / Domestic Accelerator in people with Nasopharynx Cancer and Radiotherapy, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharynx Cancer, Radiotherapy
- What is being tested?
- 3DV+TPS/VARIAN, TPS / VARIAN and 3DV + TPS / Domestic Accelerator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 May 2019
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consolidate other serious diseases that affect quality of life or treatment;
- Reluctant to actively cooperate with the investigator;
- Mergers with distant transfers;
- Patients who have undergone head and neck surgery and radiotherapy;
- Subjects who are affected by the disease who sign a written informed consent or follow the study procedure; or who are unwilling or unable to comply with the research requirements.
- Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
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- Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment;
- Pregnant or lactating women;
- The investigator judges other conditions that may affect the clinical study and the outcome of the study.
Who cannot join
- Those who did not follow the protocol.
- The subject is aggravated or has a serious adverse reaction.
- The subject himself requested to withdraw from the trial.
- The patient is lost to follow-up or died.
- The researcher believes that there is reason to withdraw
Trial locations and contacts
1 site in 1 country.
China1 site
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 40037
About this study
Official title: 3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.
Read the detailed description
The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoint was the local control rate and the incidence of treatment-related side effects.
- Conditions
- Nasopharynx Cancer, Radiotherapy
- Being tested
- 3DV+TPS/VARIAN, TPS / VARIAN, 3DV + TPS / Domestic Accelerator, TPS / Domestic Accelerator
- Keywords
- nasopharynx cancer, Radiotherapy
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DV+TPS/VARIANDevice
Use imported 3DV+TPS to map targets and develop treatment plans
TPS / VARIANDevice
Use imported TPS to map targets and develop treatment plans
3DV + TPS / Domestic AcceleratorDevice
Use domestic 3DV+TPS to delineate target areas and develop treatment plans
TPS / Domestic AcceleratorDevice
Use domestic TPS to map targets and develop treatment plans
| Study group | Role | What they receive |
|---|---|---|
| 3DV+TPS/VARIAN | Experimental | Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN. Receives: Device: 3DV+TPS/VARIAN |
| TPS/VARIAN | Active comparator | Use imported Varian TPS to map targets and develop treatment plans. Receives: Device: TPS / VARIAN |
| 3DV+TPS/ Domestic accelerator | Experimental | Use 3DV+TPS to map targets and develop treatment plans. Receives: Device: 3DV + TPS / Domestic Accelerator |
| TPS/ Domestic accelerator | Active comparator | Adopt domestic TPS hook target and develop treatment plan. Receives: Device: TPS / Domestic Accelerator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
Measured: 3 months follow-up after treatment
Secondary outcomes (2)
Local control rate
Local control means that the tumor does not increase in imaging, but if the tumor does not increase, the patient with increased symptoms after treatment is not included in the local control range.
Measured: 3 months follow-up after treatment
incidence of treatment-related side effects
Incidence of related side effects during disease treatment
Measured: 3 months follow-up after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Dec 2018
- Primary completion31 Jan 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharynx CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791944
- Sponsor's protocol ID
- XQonc-010
- Status last verified
- Feb 2024
- First submitted
- 31 Dec 2018
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT03791944
- Acronym / sponsor ID
- XQonc-010
- Conditions
- Nasopharynx Cancer, Radiotherapy
- Keywords
- nasopharynx cancer, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 3 Jan 2019 (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.
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.
Detailed description
The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoint was the local control rate and the incidence of treatment-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3DV+TPS/VARIAN | Experimental | Device: 3DV+TPS/VARIANUse 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN. |
| TPS/VARIAN | Active comparator | Device: TPS / VARIANUse imported Varian TPS to map targets and develop treatment plans. |
| 3DV+TPS/ Domestic accelerator | Experimental | Device: 3DV + TPS / Domestic AcceleratorUse 3DV+TPS to map targets and develop treatment plans. |
| TPS/ Domestic accelerator | Active comparator | Device: TPS / Domestic AcceleratorAdopt domestic TPS hook target and develop treatment plan. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Consolidate other serious diseases that affect quality of life or treatment;
- Reluctant to actively cooperate with the investigator;
- Mergers with distant transfers;
- Patients who have undergone head and neck surgery and radiotherapy;
- Subjects who are affected by the disease who sign a written informed consent or follow the study procedure; or who are unwilling or unable to comply with the research requirements.
Key exclusion criteria (5 listed)
- Those who did not follow the protocol.
- The subject is aggravated or has a serious adverse reaction.
- The subject himself requested to withdraw from the trial.
- The patient is lost to follow-up or died.
- The researcher believes that there is reason to withdraw
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 |
|---|---|---|
| 3DV+TPS/VARIANUse imported 3DV+TPS to map targets and develop treatment plans | Device | 3DV+TPS/VARIAN |
| TPS / VARIANUse imported TPS to map targets and develop treatment plans | Device | TPS/VARIAN |
| 3DV + TPS / Domestic AcceleratorUse domestic 3DV+TPS to delineate target areas and develop treatment plans | Device | 3DV+TPS/ Domestic accelerator |
| TPS / Domestic AcceleratorUse domestic TPS to map targets and develop treatment plans | Device | TPS/ Domestic accelerator |
Primary outcome
Objective response rate
Time frame: 3 months follow-up after treatment
Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
2 secondary outcomes
Local control rate
Time frame: 3 months follow-up after treatment
incidence of treatment-related side effects
Time frame: 3 months follow-up after treatment
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 23 Feb 2024.
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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?
A study testing 3DV+TPS/VARIAN, TPS / VARIAN and 3DV + TPS / Domestic Accelerator in people with Nasopharynx Cancer and Radiotherapy, run by Xinqiao Hospital of Chongqing 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 9 inclusion and 5 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 23 Feb 2024. 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?
Objective response rate (time frame: 3 months follow-up after treatment). 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 23 Feb 2024.