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Trial Title:
Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer
NCT ID:
NCT05804916
Condition:
Breast Cancer
Optical Surface Monitoring Technology
Large-segment Radiotherapy
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
optical surface monitoring technology
large-segment radiotherapy
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open Label
Intervention:
Intervention type:
Device
Intervention name:
Surface Guided Radiation Therapy (SGRT)
Description:
SGRT and DIBH those two devices could be combined together to improve the accuracy in
radiation therapy position and heart protection
Arm group label:
SGRT+DIBH group
Other name:
Deep Inspiration Breath Hold (DIBH) technique
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
aged 18-70, with an expected lifespan of >5 years
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaorong HOU, PhD
Phone:
+86-13811963013
Email:
hxr_pumch@163.com
Start date:
April 1, 2022
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804916
