3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Nasopharynx Cancer; Radiotherapy
• Intervention / Treatment: Device: 3DV+TPS/VARIAN; Device: TPS / VARIAN; Device: 3DV + TPS / Domestic Accelerator; Device: TPS / Domestic Accelerator

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 40037
      • The Second Affiliated Hospital of Army Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: December 31, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; nasopharynx cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
• Other Study ID Numbers: XQonc-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No