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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaorong HOU, PhD
hxr_pumch@163.com
+86-13811963013
Backup
Fuquan ZHANG, PhD
zhangfuquan3@126.com
+86-13311360431
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 556
Treatments
Experimental: SGRT+DIBH group
Patients with left breast cancer treated with SGRT combined with DIBH technique
No_intervention: common+Free breath group
Patients with left breast cancer treated with traditional laser alignment with free breathing treatment
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov