A clinical study to evaluate the feasibility and dose delivery accuracy of modified track Dynamic WaveArc therapy

Not Applicable

• Conditions: Breast cancer (left), Spinal metastases; APBI, Spinal metastasis; D001943, D009362

• Registration Number: JPRN-jRCT1052200034
• Lead Sponsor: Mizowaki Takashi

Brief Summary

To evaluate the feasibility of variable trajectory DWA, a novel irradiation technique using Vero4DRT, a clinical trial was conducted for breast APBI and spinal SBRT. 25 patients (12 APBI, 13 spinal SBRT) were enrolled and treated with variable trajectory DWA. All patients were able to complete the planned treatment, and the primary endpoint, protocol completion rate, was 100%.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-08
• Study Completion: 2022-03-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Left breast cancer, post surgery.
spinal metastases less than 3 lesions.

Exclusion Criteria

Severe complications.
Mental illness.
Re-irradiation.
Dose distribution of DWA is inferior to conventional radiotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of treatment protocol

Secondary Outcome Measures

Name	Time	Method
Breast cancer : acute adverse event rate, late adverse event rate, recurrence-free survival in affected breast, breast aggravation, deterioration of breast cosmetic outcomes rate, disease-free survival, overall survival<br>Spinal metastases : acute adverse event rate, late adverse event rate, local progression-free survival, recurrence-free survival, overall survival