on-interventional study about the tolerability and efficacy of chemotherapy with Oxaliplatin (Euroxaliplatin(R)) in everday use for treatment of the colorectal carcinoma
Recruiting
- Conditions
- colorectal carcinomaC18C19C20Malignant neoplasm of colonMalignant neoplasm of rectosigmoid junctionMalignant neoplasm of rectum
- Registration Number
- DRKS00005456
- Lead Sponsor
- apharm GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
•Histologically confirmed colorectal carcinoma
•Age: = 18 years
•Signed informed consent
•Capacity of the patient to consent (knowledge of manner, significance and consequences of medical operations)
•Adequate pregnancy prevention measures during the cytostatic therapy
•Therapy in an oncological doctors practice
Exclusion Criteria
•Pregnancy (in female patients)
•Period of lactation (in female patients)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact of age, BMI and comorbidity on therapy and tolerability (CTC-checklist version 4.0), effectiveness (objective response rate)
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS), impact of physical activity (questions as listed in the eCRF)