Back to resultsOptical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer
Primary Purpose
Breast Cancer, Optical Surface Monitoring Technology, Large-segment Radiotherapy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Surface Guided Radiation Therapy (SGRT)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, optical surface monitoring technology, large-segment radiotherapy
Eligibility Criteria
Inclusion Criteria: Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer; Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy; Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times; Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery; No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline; Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment. Exclusion Criteria: Bilateral breast cancer; No pathological diagnosis; Remote metastasis; Receiving neoadjuvant chemotherapy or breast reconstruction; Have received mediastinal radiotherapy in the past; Previous history of abdominal or pelvic radiotherapy; Previous or secondary primary malignant tumor; Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SGRT+DIBH group
common+Free breath group
Arm Description
Patients with left breast cancer treated with SGRT combined with DIBH technique
Patients with left breast cancer treated with traditional laser alignment with free breathing treatment
Outcomes
Primary Outcome Measures
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
Incidence of patient coronary events/myocardial perfusion decline
including the cardiac enzymes, ECG and myocardial perfusion
Secondary Outcome Measures
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
cardiac safety
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
patients' quality of life
scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.
Full Information
NCT ID
NCT05804916
First Posted
March 13, 2023
Last Updated
March 27, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05804916
Brief Title
Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Optical Surface Monitoring Technology, Large-segment Radiotherapy
Keywords
breast cancer, optical surface monitoring technology, large-segment radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Control group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH technique
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
556 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGRT+DIBH group
Arm Type
Experimental
Arm Description
Patients with left breast cancer treated with SGRT combined with DIBH technique
Arm Title
common+Free breath group
Arm Type
No Intervention
Arm Description
Patients with left breast cancer treated with traditional laser alignment with free breathing treatment
Intervention Type
Device
Intervention Name(s)
Surface Guided Radiation Therapy (SGRT)
Other Intervention Name(s)
Deep Inspiration Breath Hold (DIBH) technique
Intervention Description
SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection
Primary Outcome Measure Information:
Title
Accuracy of treatment location
Description
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
Time Frame
Change from baseline to the whole treatment procedure
Title
Incidence of patient coronary events/myocardial perfusion decline
Description
including the cardiac enzymes, ECG and myocardial perfusion
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Secondary efficacy indicators
Description
Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions
Time Frame
3-year
Title
cardiac safety
Description
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
Time Frame
5-year
Title
patients' quality of life
Description
scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.
Time Frame
5-year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
aged 18-70, with an expected lifespan of >5 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;
Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.
Exclusion Criteria:
Bilateral breast cancer;
No pathological diagnosis;
Remote metastasis;
Receiving neoadjuvant chemotherapy or breast reconstruction;
Have received mediastinal radiotherapy in the past;
Previous history of abdominal or pelvic radiotherapy;
Previous or secondary primary malignant tumor;
Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaorong HOU, PhD
Phone
+86-13811963013
Email
hxr_pumch@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fuquan ZHANG, PhD
Phone
+86-13311360431
Email
zhangfuquan3@126.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaorong HOU, PhD
Phone
+86-13811963013
Email
hxr_pumch@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer
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