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.
Recruiting
- Conditions
- C18Malignant neoplasm of colon
- Registration Number
- DRKS00026926
- Lead Sponsor
- St. Franziskus-Hospital GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
Non-consenting adults,
Minors,
Pregnant and breastfeeding women
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Statistical correlation between elevated 5-FU blood levels and incidence of serious adverse events (CTCAE grades 3 and 4
- Secondary Outcome Measures
Name Time Method Statistical correlation between 5-FU blood levels and radiologic treatment response in palliative and conversion chemotherapy.