Influence of therapeutic drug monitoring (TDM) on the tolerability and efficacy of 5-FU-containing chemotherapy in patients with colorectal carcinoma in the colorectal center at St.-Franziskus-Hospital Münster: a prospective, monocentric observational study.

Influence of therapeutic drug monitoring (TDM) on the tolerability and efficacy of 5-FU-containing chemotherapy in patients with colorectal carcinoma in the colorectal center at St.-Franziskus-Hospital Münster: a prospective, monocentric observational study. - 5FU-TDM

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026926

Enrollment

Registered

2021-10-18

Start date

2021-04-08

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

Interventions

Group 1: Patients undergoing initial adjuvant or palliative or induction chemotherapy according to the FOLFOX protocol.

Eligibility

Sex/Gender

All

Age

18 Years to 95 Years

Inclusion criteria

Inclusion criteria: - Patients with stage II and III colon cancer for whom adjuvant chemotherapy is indicated and planned according to the FOLFOX4 regimen. - Patients with stage IV colon cancer in whom palliative or conversion chemotherapy according to the FOLFOX4 +/- bevacizumab regimen is indicated and planned.

Exclusion criteria

Exclusion criteria: Non-consenting adults, Minors, Pregnant and breastfeeding women

Design outcomes

Primary

Measure	Time frame
Statistical correlation between elevated 5-FU blood levels and incidence of serious adverse events (CTCAE grades 3 and 4	—

Secondary

Measure	Time frame
Statistical correlation between 5-FU blood levels and radiologic treatment response in palliative and conversion chemotherapy.	—

Countries

Germany

Contacts

Public ContactValeria Carobin

St. Franziskus-Hospital GmbHKlinik für Innere Medizin II

valeria.carobin@sfh-muenster.de+49 251 935 -3906

Outcome results

None listed

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