Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed.
Recruiting
- Conditions
- Breast cancer
- Registration Number
- NL-OMON21034
- Lead Sponsor
- Prof. dr H. Bartelink, AvL/NKI, Plesmanlaan 121, 1069 CX Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1160
Inclusion Criteria
1. Age 50 years or younger;
2. Histological diagnosis of invasive mammary cancer including all subtypes of
invasive adenocarcinoma;
Exclusion Criteria
1. Residual microcalcifications on mammogram;
2. All histological types of malignancies other than invasive adenocarcinoma;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal control at 10 yr.
- Secondary Outcome Measures
Name Time Method 1. Cosmetic outcome.<br /><br><strong>Additional objectives:</strong><br /><br><strong>A.</strong> To test the genotypic and phenotypic profiles of breast tumors [van de Vijver et al.,2002] in young patients with invasive breast cancer, and its relation to:<br /><br>a. Local recurrence after BCT;<br /><br>b. Lymph node metastases;<br /><br>c. Distant metastases and surviva;<br /><br>d. Radiosensitivity;<br /><br>e. Age;<br /><br><strong>B.</strong> To determine whether improved genotypic and phenotypic profiles can be determined related to the endpoints mentioned in A.