C18 C19 C20
Conditions
Interventions
Group 1: This non-interventional study is observing a patient population with histologically or cytologically diagnosed colorectal cancer, for which the treatment with oxaliplatin LIV Pharma is indic
Sponsors
LIV Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • histological or cytological diagnosed colorectal, where Oxaliplatin LIV is indicated according to SPC • Age: over 18 years • Oxaliplatin LIV is used in therapy. • A manually signed and dated informed consent is present. • The therapy was chosen independently from possible enrollment
Exclusion criteria
Exclusion criteria: • contraindications to the use of Oxaliplatin LIV Pharma according to SPC • The current therapy was started more than 12 weeks ago. • The patient is participatiing in a clinical trial • A pregnancy is present or the patient is breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Effecacy under practical conditions. In detail: Was therapy with Irinotecan LIV Pharma discontinued within the planned therapy period and at what therapy success and what are the eventual discontinuation reasons collected at each visit and remission duration during the follow-up phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Tolerability under real-life conditions according to NCI/CTC criteria during the entire duration of the study, including the follow-up phase. - Quality of life and mental state assessed by FACT-C and Trier Scales for Disease Management (TSK) at baseline, cycle 3, final examination and at each follow-up examination, and Hospital Axiety. - Disease coping assessed by Depression Scale (HADS) at baseline and follow-up. - Adverse events not yet observed during the entire study period including the follow-up phase. | — |
Countries
Germany
Contacts
Public ContactBurkard Heckelbacher
Datafaber GbR
Outcome results
None listed