3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.

Detailed Description
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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.

Official Title
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3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study

Conditions
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Nasopharynx Cancer, Radiotherapy

Intervention / Treatment
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* Device: 3DV+TPS/VARIAN
* Device: TPS / VARIAN
* Device: 3DV + TPS / Domestic Accelerator
* Device: TPS / Domestic Accelerator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3DV+TPS/VARIAN<br>Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN. | Device: 3DV+TPS/VARIAN<br>* Use imported 3DV+TPS to map targets and develop treatment plans<br>|
| Active Comparator: TPS/VARIAN<br>Use imported Varian TPS to map targets and develop treatment plans. | Device: TPS / VARIAN<br>* Use imported TPS to map targets and develop treatment plans<br>|
| Experimental: 3DV+TPS/ Domestic accelerator<br>Use 3DV+TPS to map targets and develop treatment plans. | Device: 3DV + TPS / Domestic Accelerator<br>* Use domestic 3DV+TPS to delineate target areas and develop treatment plans<br>|
| Active Comparator: TPS/ Domestic accelerator<br>Adopt domestic TPS hook target and develop treatment plan. | Device: TPS / Domestic Accelerator<br>* Use domestic TPS to map targets and develop treatment plans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR) | 3 months follow-up after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months follow-up after treatment | 
| incidence of treatment-related side effects | Incidence of related side effects during disease treatment | 3 months follow-up after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasopharynx cancer, Radiotherapy