3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Nasopharynx Cancer; Radiotherapy

Treatments: Device: TPS / VARIAN; Device: 3DV + TPS / Domestic Accelerator; Device: TPS / Domestic Accelerator; Device: 3DV+TPS/VARIAN

Study type: Interventional

Funder types: Other

Identifiers

NCT03791944

XQonc-010

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

3DV+TPS/VARIAN

Experimental group

Description:

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

Treatment:

Device: 3DV+TPS/VARIAN

TPS/VARIAN

Active Comparator group

Description:

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

Treatment:

Device: TPS / VARIAN

3DV+TPS/ Domestic accelerator

Experimental group

Description:

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

Treatment:

Device: 3DV + TPS / Domestic Accelerator

TPS/ Domestic accelerator

Active Comparator group

Description:

Adopt domestic TPS hook target and develop treatment plan.

Treatment:

Device: TPS / Domestic Accelerator