Online adaptive radiotherapy for breast cancer treatment
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
This study is testing a new way of giving radiation therapy for breast cancer to see if it can deliver treatment more accurately and safely while reducing side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06568705 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of online adaptive radiotherapy in patients receiving moderate hypofractionated or ultrafractionated radiotherapy following breast cancer surgery. The study aims to determine if this innovative approach can enhance the precision of dose delivery and evaluate the associated treatment-related toxicities and tumor control outcomes. Participants will receive either 43.5Gy in 15 fractions or 26Gy in 5 fractions of radiotherapy, utilizing advanced imaging and artificial intelligence for real-time treatment adjustments. The goal is to improve patient outcomes while minimizing side effects.
Who should consider this trial
Good fit: Ideal candidates are females aged 35 to 70 who have undergone breast-conserving surgery or modified radical mastectomy for pathologically confirmed primary breast cancer.
Not a fit: Patients with confirmed metastasis, previous radiation therapy to the neck or chest, or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer radiotherapy options for breast cancer patients.
How similar studies have performed: Previous studies have shown promising results with moderate hypofractionated radiotherapy, suggesting that this adaptive approach may also yield positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, aged ≥35 years, \<70 years * ECOG score: 0-2 * Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection * Pathologically confirmed primary breast cancer * For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1 * Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy * Able to cooperate and tolerate the treatment Exclusion Criteria: * Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis * History of radiotherapy to the neck or chest * Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.) * History of malignant tumors
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiaorong Hou, MD
- Email: hxr_pumch@163.com
- Phone: +86-13811963013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.