3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma
1 other identifier
interventional
100
1 country
1
Brief Summary
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 31, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedFebruary 23, 2024
February 1, 2024
2 months
December 31, 2018
February 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
3 months follow-up after treatment
Secondary Outcomes (2)
Local control rate
3 months follow-up after treatment
incidence of treatment-related side effects
3 months follow-up after treatment
Study Arms (4)
3DV+TPS/VARIAN
EXPERIMENTALUse 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.
TPS/VARIAN
ACTIVE COMPARATORUse imported Varian TPS to map targets and develop treatment plans.
3DV+TPS/ Domestic accelerator
EXPERIMENTALUse 3DV+TPS to map targets and develop treatment plans.
TPS/ Domestic accelerator
ACTIVE COMPARATORAdopt domestic TPS hook target and develop treatment plan.
Interventions
Use domestic 3DV+TPS to delineate target areas and develop treatment plans
Use domestic TPS to map targets and develop treatment plans
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 40037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director
Study Record Dates
First Submitted
December 31, 2018
First Posted
January 3, 2019
Study Start
December 1, 2018
Primary Completion
January 31, 2019
Study Completion
May 31, 2019
Last Updated
February 23, 2024
Record last verified: 2024-02