Intraoperative radiotherapy during breast cancer surgery
Phase 2
Recruiting
- Conditions
- Breast cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20191123045474N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Pathologic diagnosis of invasive ductal breast cancer
Breast cancer with size less than or equal to 3 cm
No lymph node involvement
No distant metastases
Exclusion Criteria
Pregnancy
Lactation
Active collagen vascular diseases such as scleroderma
Previous radiotherapy in diseases such as Hodgkin's lymphoma
Multifocal breast cancer
Presence of distant metastasis
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival. Timepoint: Two years after completion of treatment. Method of measurement: Physical examination and breast imaging.;Overall survival. Timepoint: Two years after completion of treatment. Method of measurement: Follow up of patient.;Skin toxicity. Timepoint: Two years after completion of treatment. Method of measurement: Physical examination based on toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer.;Subcutaneous toxicity. Timepoint: Two years after completion of treatment. Method of measurement: Physical examination based on toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer.
- Secondary Outcome Measures
Name Time Method