Prospective observational study to assess the efficacy and tolerability of axiplatin® using different timing regimens and doses in clinical practice in patients with stage III colon carcinoma (Dukes C) or metastatic colorectal carcinoma (short title: FREDOS).

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

• Registration Number: DRKS00004794
• Lead Sponsor: AxioNovo GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-06
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 575

Inclusion Criteria

Patients with stage III colon carcinoma (Dukes C) for whom therapy with axiplatin® is indicated according to the SmPC.
- Patients with metastatic colorectal cancer for whom therapy with axiplatin® is indicated according to the SmPC.
- Age: older than 18 years
- Axiplatin is used in therapy.
- A hand-dated and signed informed consent is available.
- Therapy was selected independent of potential study inclusion.

Exclusion Criteria

- Contraindications to the use of Epirubicin LIV Pharma according to the SmPC.
- The current therapy was started more than 12 weeks ago.
- The patient is participating in a clinical trial at the same time.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete remission at end of observation period assessed by clinical examination, or laboratory assessments or imaging.

Secondary Outcome Measures

Name	Time	Method
Toxicities of grade IV during treatment period diagnosed through clinical examination or laboratory.