NCT03791944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

December 31, 2018

Last Update Submit

February 22, 2024

Conditions

Keywords

nasopharynx cancerRadiotherapy

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

EXPERIMENTAL

Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.

Device: 3DV+TPS/VARIAN

TPS/VARIAN

ACTIVE COMPARATOR

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

Device: TPS / VARIAN

3DV+TPS/ Domestic accelerator

EXPERIMENTAL

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

Device: 3DV + TPS / Domestic Accelerator

TPS/ Domestic accelerator

ACTIVE COMPARATOR

Adopt domestic TPS hook target and develop treatment plan.

Device: TPS / Domestic Accelerator

Interventions

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

3DV+TPS/VARIAN

Use imported TPS to map targets and develop treatment plans

TPS/VARIAN

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

3DV+TPS/ Domestic accelerator

Use domestic TPS to map targets and develop treatment plans

TPS/ Domestic accelerator

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

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

Locations