Using advanced technology for precise radiotherapy in breast cancer treatment

A Single-center, Blinded, Efficacious, Phase III Randomized Clinical Trial Initiated by Investigators 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 study tests if a new way of delivering radiation therapy for left breast cancer can improve treatment accuracy and protect the heart better than traditional methods.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 556 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05804916 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Surface Guided Radiation Therapy (SGRT) combined with the Deep Inspiration Breath Hold (DIBH) technique for treating left breast cancer. It compares this innovative approach to traditional laser alignment methods during free breathing. The study aims to enhance positioning accuracy and protect the heart without increasing radiation exposure or adverse effects. The primary focus is on measuring treatment accuracy and monitoring any coronary events or myocardial perfusion decline in patients.

Who should consider this trial

Good fit: Ideal candidates include patients who have undergone surgery for left breast cancer and can perform the deep inspiration breath-hold technique.

Not a fit: Patients with bilateral breast cancer, active heart disease, or those who have received prior mediastinal radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate radiotherapy for breast cancer patients, reducing heart-related side effects.

How similar studies have performed: Other studies have shown promising results with similar techniques, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Xiaorong HOU, PhD

Conditions: Breast Cancer, Optical Surface Monitoring Technology, Large-segment Radiotherapy, breast cancer, optical surface monitoring technology, large-segment radiotherapy