Results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy
Phase 2
Recruiting
- Conditions
- Breast cancer.Breast, unspecified
- Registration Number
- IRCT2017091428815N2
- Lead Sponsor
- Vice-chancellery for Research of Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Women between 30 and 70 years old; informed consent for participation; pathologic confirmation of invasive ductal carcinoma of breast; tumor stages of T3N1M0, T3N0M0, T2N1M0, and T2N0M0 based on classification of American Joint Committee on Cancer; and operable breast cancer patient who is candidate for breast conserving surgery.
Exclusion criteria: Pregnancy and breast feeding; active collagen vascular diseases like scleroderma; history of chest wall radiotherapy for Hodgkin lymphoma; multifocal breast cancer in two separate quadrants of breast; presence of metastasis during treatment; and poor clinical response to the neoadjuvant chemotherapy.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year disease-free survival. Timepoint: every 3 months. Method of measurement: physical examination and mammography.
- Secondary Outcome Measures
Name Time Method Dermatitis. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.;Skin necrosis. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.;Beauty. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.