Radiation therapy during surgery for low grade ductal carcinoma in situ breast cancer
Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer
This study tests if giving radiation during surgery for women with low grade ductal carcinoma in situ breast cancer can improve their treatment results compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Guangdong Academy of Medical Sciences Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02389673 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intraoperative radiotherapy for women with low grade ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery. The approach involves administering radiation during the surgical procedure, followed by external-beam radiation to the entire breast, to potentially enhance tumor cell destruction. The study aims to determine if this method improves outcomes compared to traditional treatment protocols. Participants must have undergone lumpectomy with negative margins and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are women with low grade ductal carcinoma in situ who are eligible for breast-conserving surgery and have tumors smaller than 5 cm.
Not a fit: Patients with intermediate or high grade ductal carcinoma in situ, invasive carcinoma, or those with larger tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for women with low grade DCIS, potentially reducing the risk of recurrence.
How similar studies have performed: Other studies have explored intraoperative radiotherapy, showing promising results, but this specific approach for low grade DCIS is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tumor diameter \< 5 cm * Low grade ductal carcinoma in situ * Candidate for breast-conserving surgery * Must have undergone lumpectomy with negative margins or minimal margin involvement * Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection * No evidence of metastatic disease * Informed consent Exclusion Criteria: * No informed consent * Tumor size \> 5 cm * Intermediate or high grade ductal carcinoma in situ * Invasive carcinoma * No indication for a boost
Where this trial is running
Guangzhou, Guangdong
- Guangdong Academy of Medical Sciences — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Liao Ning, MD,PhD
- Phone: +86 83827812
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.