CClinicalTrials.gg
CompletedNCT03791944Updated Feb 23, 2024

3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

An interventional study of 3DV+TPS/VARIAN and TPS / VARIAN in Nasopharynx Cancer and Radiotherapy, sponsored by Xinqiao Hospital of Chongqing. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Xinqiao Hospital of Chongqing · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Nasopharynx Cancer
  • Radiotherapy

Keywords

  • nasopharynx cancer
  • Radiotherapy
03

In context

Nasopharyngeal Carcinoma

816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.

This study's enrollment of 100 is above the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Xinqiao Hospital of Chongqing is the lead sponsor of 68 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • 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

  • Active comparator
    TPS/VARIAN

    Use imported Varian TPS to map targets and develop treatment plans.

    Device: TPS / VARIAN

  • Experimental
    3DV+TPS/ Domestic accelerator

    Use 3DV+TPS to map targets and develop treatment plans.

    Device: 3DV + TPS / Domestic Accelerator

  • Active comparator
    TPS/ Domestic accelerator

    Adopt domestic TPS hook target and develop treatment plan.

    Device: TPS / Domestic Accelerator

Interventions

  • Device3DV+TPS/VARIAN

    Use imported 3DV+TPS to map targets and develop treatment plans

  • DeviceTPS / VARIAN

    Use imported TPS to map targets and develop treatment plans

  • Device3DV + TPS / Domestic Accelerator

    Use domestic 3DV+TPS to delineate target areas and develop treatment plans

  • DeviceTPS / Domestic Accelerator

    Use domestic TPS to map targets and develop treatment plans

06

What researchers measure

Primary outcomes

  1. Objective response rate

    Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)

    Time frame: 3 months follow-up after treatment

Secondary outcomes

  1. 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.

    Time frame: 3 months follow-up after treatment

  2. incidence of treatment-related side effects

    Incidence of related side effects during disease treatment

    Time frame: 3 months follow-up after treatment

07

Study locations

1 site
  • the second affiliated hospital of Army medical university
    Chongqing, Chongqing 40037, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03791944
Lead sponsor
Xinqiao Hospital of Chongqing
Responsible party
Jianguo Sun (Deputy director, Xinqiao Hospital of Chongqing) — Principal investigator
First posted
Jan 3, 2019
Start date
Dec 1, 2018
Primary completion
Jan 31, 2019
Completion
May 31, 2019
Last update
Feb 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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