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Clinical Trials/NL-OMON52496
NL-OMON52496
Recruiting
Not Applicable

A combination of pre-screening for DPD deficiency by genotyping/phenotyping methods and pharmacokinetics-guided dosing of 5-FU for precision treatment to prevent severe toxicity in gastrointestinal cancer patients. - DPD guided 5FU precision treatment in GI cancer

Isala Klinieken0 sites75 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Isala Klinieken
Enrollment
75
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Isala Klinieken

Eligibility Criteria

Inclusion Criteria

  • age 18 years and older
  • histological proof of gastro\-intestinal cancer
  • patient is considered for treatment with capecitabine or 5\-FU
  • acceptable safety laboratory values
  • ECOG performance status 0\-2
  • able and willing to give written informed consent
  • able and willing to undergo blood sampling for DPYD genotyping, DPD
  • phenotyping and pharmacokinetic analysis

Exclusion Criteria

  • symptomatic or uncontrolled central nervous system metastases
  • patient who cannot submit itself to the formal follow\-up for psychological,
  • social, family or geographical reasons
  • women who are pregnant or breast\-feeding
  • women not consenting to use adequate contraceptive precautions during the
  • significant serious pathology or any instable medical condition (cardiac
  • pathology uncontrolled, myocardial infarction within 6 months before enrolment,
  • systemic active uncontrolled infection, cirrhosis (Child\-Pugh score C), renal
  • failure (GFR \< 20 ml/min))
  • any investigational agent within 4 weeks before enrolment

Outcomes

Primary Outcomes

Not specified

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