Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 70Years
FEMALE
NCT05804916

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

Led by Peking Union Medical College Hospital · Updated on 2023-04-07

556

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who had breast-conserving surgery or modified radical mastectomy for left breast cancer
  • Planned radiotherapy to whole breast with or without supraclavicular region, or chest wall with or without supraclavicular region
  • Able to perform deep inspiration breath-hold with breath-holding time over 35 seconds and repeat it more than 6 times continuously
  • Have not received neoadjuvant chemotherapy or breast reconstruction surgery
  • No active heart disease, myocardial infarction, congestive heart failure, or other cardiac diseases at baseline
  • Voluntary and able to sign informed consent form 30 days before enrollment
Not Eligible

You will not qualify if you...

  • Bilateral breast cancer
  • No pathological diagnosis
  • Distant metastasis
  • Receiving neoadjuvant chemotherapy or breast reconstruction
  • Previous mediastinal radiotherapy
  • Previous abdominal or pelvic radiotherapy
  • Previous or secondary primary malignant tumor
  • Serious cardiac insufficiency
  • Myocardial infarction, uncorrected unstable arrhythmia, or unstable angina pectoris within last 3 months
  • Pericardial disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

X

Xiaorong HOU, PhD

CONTACT

F

Fuquan ZHANG, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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