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Completed

NCT Number: NCT03791944

3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3DV+TPS/VARIAN

Device

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

TPS / VARIAN

Device

Use imported TPS to map targets and develop treatment plans

3DV + TPS / Domestic Accelerator

Device

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

TPS / Domestic Accelerator

Device

Use domestic TPS to map targets and develop treatment plans

Primary outcomes

  1. Objective response rate

    Time frame: 3 months follow-up after treatment

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

Secondary outcomes

  1. Local control rate

    Time frame: 3 months follow-up after treatment

    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.

  2. incidence of treatment-related side effects

    Time frame: 3 months follow-up after treatment

    Incidence of related side effects during disease treatment

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2019
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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