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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Breast Cancer; Optical Surface Monitoring Technology; Large-segment Radiotherapy

Treatments: Device: Surface Guided Radiation Therapy (SGRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05804916

SGRT-BC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 556 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

556 participants in 2 patient groups

SGRT+DIBH group

Experimental group

Description:

Patients with left breast cancer treated with SGRT combined with DIBH technique

Treatment:

Device: Surface Guided Radiation Therapy (SGRT)

common+Free breath group

No Intervention group

Description:

Patients with left breast cancer treated with traditional laser alignment with free breathing treatment