MedDRA - Colorectal carcinoma (10010036) C18
Conditions
Interventions
Group 1: Patients treated with Oxaliplatin Omnicare are asked to complete a questionnaire every 3 months under therapy and every 6 months after end of treatment. The questionnaire contains questions r
Sponsors
OMNICARE Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male and female patients = 18 years 2.Diagnosis of metastatic colorectal carcinoma for which a palliative chemotherapy is indicated or of a colon carcinoma of stage III (Dukes C) after complete resection of the primary tumor for which an adjuvant chemotherapy is indicated 3.Investigator's decision (independent of study participation) to treat the patient with Oxaliplatin Omnicare® 4.Sufficient patient's compliance upon investigator's assessment 5.Written informed consent of the patient to retrospective and prospective pseudonomized documentation, to forwarding and analysis of the data and to access to the data within monitoring
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of grade and duration of neurotoxicity for patients under therapy with Oxaliplatin Omnicare by means of a patient questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of neurotoxicity by the investigator by means of CTCAE criteria (version 4.0) • Evaluation of adverse drug reactions of Oxaliplatin Omnicare® | — |
Countries
Germany
Contacts
Public ContactCaroline Schneider
Institut Dr. Schauerte
Outcome results
None listed