3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

NCT ID: NCT03791944

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nasopharynx Cancer Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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3DV+TPS/VARIAN

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

Group Type EXPERIMENTAL

3DV+TPS/VARIAN

Intervention Type DEVICE

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

TPS/VARIAN

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

Group Type ACTIVE_COMPARATOR

TPS / VARIAN

Intervention Type DEVICE

Use imported TPS to map targets and develop treatment plans

3DV+TPS/ Domestic accelerator

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

Group Type EXPERIMENTAL

3DV + TPS / Domestic Accelerator

Intervention Type DEVICE

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

TPS/ Domestic accelerator

Adopt domestic TPS hook target and develop treatment plan.

Group Type ACTIVE_COMPARATOR

TPS / Domestic Accelerator

Intervention Type DEVICE

Use domestic TPS to map targets and develop treatment plans

Interventions

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3DV+TPS/VARIAN

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

Intervention Type DEVICE

TPS / VARIAN

Use imported TPS to map targets and develop treatment plans

Intervention Type DEVICE

3DV + TPS / Domestic Accelerator

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

Intervention Type DEVICE

TPS / Domestic Accelerator

Use domestic TPS to map targets and develop treatment plans

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

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Jianguo Sun

Deputy director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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XQonc-010

Identifier Type: -

Identifier Source: org_study_id

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