Back to results3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma
Primary Purpose
Nasopharynx Cancer, Radiotherapy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3DV+TPS/VARIAN
TPS / VARIAN
3DV + TPS / Domestic Accelerator
TPS / Domestic Accelerator
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharynx Cancer focused on measuring nasopharynx cancer, Radiotherapy
Eligibility Criteria
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
Sites / Locations
- the second affiliated hospital of Army medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
3DV+TPS/VARIAN
TPS/VARIAN
3DV+TPS/ Domestic accelerator
TPS/ Domestic accelerator
Arm Description
Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.
Use imported Varian TPS to map targets and develop treatment plans.
Use 3DV+TPS to map targets and develop treatment plans.
Adopt domestic TPS hook target and develop treatment plan.
Outcomes
Primary Outcome Measures
Objective response rate
Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
Secondary Outcome Measures
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.
incidence of treatment-related side effects
Incidence of related side effects during disease treatment
Full Information
NCT ID
NCT03791944
First Posted
December 31, 2018
Last Updated
December 31, 2018
Sponsor
Xinqiao Hospital of Chongqing
1. Study Identification
Unique Protocol Identification Number
NCT03791944
Brief Title
3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma
Official Title
3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharynx Cancer, Radiotherapy
Keywords
nasopharynx cancer, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3DV+TPS/VARIAN
Arm Type
Experimental
Arm Description
Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.
Arm Title
TPS/VARIAN
Arm Type
Active Comparator
Arm Description
Use imported Varian TPS to map targets and develop treatment plans.
Arm Title
3DV+TPS/ Domestic accelerator
Arm Type
Experimental
Arm Description
Use 3DV+TPS to map targets and develop treatment plans.
Arm Title
TPS/ Domestic accelerator
Arm Type
Active Comparator
Arm Description
Adopt domestic TPS hook target and develop treatment plan.
Intervention Type
Device
Intervention Name(s)
3DV+TPS/VARIAN
Intervention Description
Use imported 3DV+TPS to map targets and develop treatment plans
Intervention Type
Device
Intervention Name(s)
TPS / VARIAN
Intervention Description
Use imported TPS to map targets and develop treatment plans
Intervention Type
Device
Intervention Name(s)
3DV + TPS / Domestic Accelerator
Intervention Description
Use domestic 3DV+TPS to delineate target areas and develop treatment plans
Intervention Type
Device
Intervention Name(s)
TPS / Domestic Accelerator
Intervention Description
Use domestic TPS to map targets and develop treatment plans
Primary Outcome Measure Information:
Title
Objective response rate
Description
Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
Time Frame
3 months follow-up after treatment
Secondary Outcome Measure Information:
Title
Local control rate
Description
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.
Time Frame
3 months follow-up after treatment
Title
incidence of treatment-related side effects
Description
Incidence of related side effects during disease treatment
Time Frame
3 months follow-up after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
the second affiliated hospital of Army medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
40037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianguo sun, Phd
Phone
023-68774490
Email
sunjg09@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma
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