Influence of inflammatory processes during radiotherapy on circulating epithelial tumor cells (CETC) and the formation of tumorspheres, as well as the effect of non-steroidal anti-inflammatory drugs (NSAID) on the growth behavior of tumorspheres
Recruiting
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00011840
- Lead Sponsor
- Transfusionsmedizinisches Zentrum Bayreuth, Labor Dr. Pachmann Bayreuth
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
• histologically confirmed invasive breast carcinoma
• age >= 18 years
• exclusive treatment at the Jena University Hospital
• Complete curative-intended adjuvant or definite radiotherapy (achieved total dose = 50 Gy normo- or hypofraction)
• at least 3 blood samples (before the start of therapy, half of the fractions, after the end of RT, 6 weeks after the end of RT)
• Dose concepts:
Hypofraction up to 42.56 (2.66) Gy, normofraction to 50.0 (2.0) Gy followed by a boost up to 16.0 Gy, 5 Fx / week
Exclusion Criteria
• Lack of willingness to consent
• Presence of metastases
• Recurrence
• DCIS, inflammatory breast carcinoma
• Second malignancy <10 years before diagnosis of breast cancer
• Radiation therapy in anamnesis
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of CETCs on the first irradiation day, half of the fractions, on the last irradiation day, and 6 weeks after end of radiation therapy (maintrac), overall survival (follow up on cancer registries after 3 & 5 years) disease-free survival 3 & 5 years)
- Secondary Outcome Measures
Name Time Method Effect of non-steroidal anti-inflammatory drugs (NSAID) on the growth behavior of tumorspheres