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).

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). - FREDOS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004794

Enrollment

500

Registered

2013-03-06

Start date

2012-05-03

Completion date

Unknown

Last updated

2026-01-12

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: Patients with stage III colon cancer (Dukes C) or metastatic colorectal carcinoma for whom axiplatin® therapy is indicated according to SmPC.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Complete remission at end of observation period assessed by clinical examination, or laboratory assessments or imaging.	—

Secondary

Measure	Time frame
Toxicities of grade IV during treatment period diagnosed through clinical examination or laboratory.	—

Countries

Germany

Contacts

Public ContactBurkard Heckelbacher

Datafaber Gbr

Heckelbacher@datafaber.de+49 8161 885 107

Outcome results

None listed

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