Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer

Phase 2

Recruiting

• Conditions: Optical Surface Monitoring Technology; Breast Cancer; Large-segment Radiotherapy
• Interventions: Device: Surface Guided Radiation Therapy (SGRT)

• Registration Number: NCT05804916
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.

Detailed Description

This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 556

Inclusion Criteria

1. Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
2. Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
3. Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;
4. Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
5. No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
6. Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.

Exclusion Criteria

1. Bilateral breast cancer;
2. No pathological diagnosis;
3. Remote metastasis;
4. Receiving neoadjuvant chemotherapy or breast reconstruction;
5. Have received mediastinal radiotherapy in the past;
6. Previous history of abdominal or pelvic radiotherapy;
7. Previous or secondary primary malignant tumor;
8. Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGRT+DIBH group	Surface Guided Radiation Therapy (SGRT)	Patients with left breast cancer treated with SGRT combined with DIBH technique

Primary Outcome Measures

Name	Time	Method
Accuracy of treatment location	Change from baseline to the whole treatment procedure	surface optical monitoring technology and simulation of surface contour registration error generated by surface optical surface error, as well as errors obtained by Cone beam CT registration. The translational errors in the left-right (x), up-down (y), front-back (z) directions, and rotational errors Rx, Ry, Rz will be measured
Incidence of patient coronary events/myocardial perfusion decline	3-year	including the cardiac enzymes, ECG and myocardial perfusion

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy indicators	3-year	Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions
cardiac safety	5-year	cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
patients' quality of life	5-year	scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China