3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791944
• Other study ID #: XQonc-010
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Nasopharynx Cancer
• Radiotherapy

Intervention

Device:
• 3DV+TPS/VARIAN
Use imported 3DV+TPS to map targets and develop treatment plans
• TPS / VARIAN
Use imported TPS to map targets and develop treatment plans
• 3DV + TPS / Domestic Accelerator
Use domestic 3DV+TPS to delineate target areas and develop treatment plans
• TPS / Domestic Accelerator
Use domestic TPS to map targets and develop treatment plans

Locations

Country	Name	City	State
China	the second affiliated hospital of Army medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)	3 months follow-up after treatment
Secondary	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
Secondary	incidence of treatment-related side effects	Incidence of related side effects during disease treatment	3 months follow-up after treatment