Nasopharynx Cancer, Radiotherapy
Conditions
Keywords
nasopharynx cancer, Radiotherapy
Brief summary
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.
Interventions
DEVICE3DV+TPS/VARIAN
Use imported 3DV+TPS to map targets and develop treatment plans
DEVICETPS / VARIAN
Use imported TPS to map targets and develop treatment plans
DEVICE3DV + TPS / Domestic Accelerator
Use domestic 3DV+TPS to delineate target areas and develop treatment plans
DEVICETPS / Domestic Accelerator
Use domestic TPS to map targets and develop treatment plans
Sponsors
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Consolidate other serious diseases that affect quality of life or treatment; 2. Reluctant to actively cooperate with the investigator; 3. Mergers with distant transfers; 4. Patients who have undergone head and neck surgery and radiotherapy; 5. 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. 6. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 7. Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment; 8. Pregnant or lactating women; 9. The investigator judges other conditions that may affect the clinical study and the outcome of the study.
Exclusion criteria
1. Those who did not follow the protocol. 2. The subject is aggravated or has a serious adverse reaction. 3. The subject himself requested to withdraw from the trial. 4. The patient is lost to follow-up or died. 5. The researcher believes that there is reason to withdraw
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 months follow-up after treatment | Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate | 3 months follow-up after treatment | 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. |
| incidence of treatment-related side effects | 3 months follow-up after treatment | Incidence of related side effects during disease treatment |
Countries
China
Outcome results
None listed