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
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.
Study Type
Interventional
Primary Outcome
Objective response rate
Secondary Outcome
Local control rate
Condition
Nasopharynx Cancer
Intervention
3DV+TPS/VARIAN
Study Arms / Comparison Groups
3DV+TPS/VARIAN
Description: Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
December 1, 2018
Completion Date
May 31, 2019
Primary Completion Date
January 31, 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03791944
Organization ID
XQonc-010
Responsible Party
Principal Investigator
Study Sponsor
Xinqiao Hospital of Chongqing
Study Sponsor
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Verification Date
December 2018