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Prospective non-interventional double study about gender specific differences in the treatment of colorectal cancer - Version: Treatment with Irinotecan containing regimens LIV Pharma

Prospective non-interventional double study about gender specific differences in the treatment of colorectal cancer - Version: Treatment with Irinotecan containing regimens LIV Pharma - Colorsex-I

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009342
Enrollment
500
Registered
2015-09-10
Start date
2016-02-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C18 C19 C20

Interventions

Group 1: This non-interventional study is observing a patient population with histologically or cytologically diagnosed colorectal cancer, for which the treatment with Irinotecan LIV Pharma is indica

Sponsors

LIV Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: indicated according to SPC • Age: over 18 years • Irinotecan 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 Irinotecan 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

MeasureTime frame
Efficacy and Tolerability routine practice. Observational, non-interventional study. In detail: Was therapy completed as planned and what was the response.

Secondary

MeasureTime frame
Quality of life and aide effects which were not observed so far. QoL will be assessed by FACT-C, Scales of oping with the illness (Trierer Skalen zur Krankheitsbewältigung) TSK and and Hospital Axiety and Depression Scale (HADS).

Countries

Germany

Contacts

Public ContactJan Janssen

Praxis für Innere Medizin,Hämatologie und Onkologie, Notfallmedizin

info@onkologie-westerstede.de+49 4488-521888-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026