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

• Conditions: C18; C19; C20; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of colon; Malignant neoplasm of rectum

• Registration Number: DRKS00009342
• Lead Sponsor: IV Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-10
• Study Completion: 2017-10-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 80

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

• 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).