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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804916
• Other study ID #: SGRT-BC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Xiaorong HOU, PhD
• Phone: +86-13811963013
• Email: hxr_pumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 556
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Surface Guided Radiation Therapy (SGRT)
SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of treatment location	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	Change from baseline to the whole treatment procedure
Primary	Incidence of patient coronary events/myocardial perfusion decline	including the cardiac enzymes, ECG and myocardial perfusion	3-year
Secondary	Secondary efficacy indicators	Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions	3-year
Secondary	cardiac safety	cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc	5-year
Secondary	patients' quality of life	scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.	5-year