Implementation of Pre-emptive Geno- and Phenotyping in 5-Fluorouracil- or Capecitabine-treated Patients

NCT04269369 | Unknown Phase 4

• 1 other identifier: FluorouracilCapecitabine001
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate if the systematic implementation of pre-emptive geno- and phenotyping, and therefore a dose reduction based on the French guidelines and the literature during the first month of treatment, reduces grade 3 or greater toxicity in patients treated with 5-FU (5-fluorouracil) or capecitabine. Therefore, a monocentric, partial prospective and partial retrospective trail was designed.

Conditions

Colon Cancer; Stomach Tumor; Anal Tumor; Pancreas Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• The frequency of severe fluoropyrimidine-related toxicity

  The primary endpoint of the study is the frequency of severe (National Cancer Institute Common Terminology Criteria for Adverse Events version 5 grade ≥3) fluoropyrimidine-related toxicity across the entire treatment duration. Toxicity incidence between DPYD variant allele carriers and DPYD wild-type patients and poor or intermediate metabolizers and extensive metabolizers will be compared.

  about 3 months

Study Arms (2)

Group A

EXPERIMENTAL

Dosage according to French guidelines

Drug: 5-Fluorouracil

Group B

EXPERIMENTAL

Dosage according to literature

Drug: 5-Fluorouracil

Interventions

5-Fluorouracil DRUG

The aim of this study is to investigate if the systematic implementation of pre-emptive geno- and phenotyping, and therefore a dose reduction based on the French guidelines and the literature during the first month of treatment, reduces grade 3 or greater toxicity in patients treated with 5-FU or capecitabine. Therefore a dosing table was obtained by combining the results of the study by Henricks et al., Launay et al. and Yang et al. and the recommendations from the French HAS guideline. The treatment schedule then will be discussed by the team of doctors and paramedics at the weekly MOC (multidisciplinary cancer consultation). Complementary, the pharmacist provides dose advice with regard to the start of 5-FU or capecitabine treatment. In a subgroup, the group of patients with genotype "wild type" and phenotype "intermediate metabolizer", a comparison will be made between group A with dosage according to French guidelines and group B with dosage according to literature.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older
• WHO (world health organization) classification 0,1 or 2
• A suspected start with 5-FU or capecitabine in mono or combination therapy
• The knowledge of the result of the geno and phenotyping before the start of the treatment

You may not qualify if:

• Homozygote genotype or uracil 100 ng/ml or greater
• The lacking of the result of the geno and / or phenotyping before the start of treatment
• Patients who received 5-FU or capecitabine in the past

Sponsors & Collaborators

• Jessa Hospital: lead

MeSH Terms

Conditions

Colonic Neoplasms; Stomach Neoplasms; Anus Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Rectal Neoplasms; Anus Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• An Lambaerts

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

An Lambaerts

CONTACT

+3211338461; an.lambaerts@jessazh.be

Liesbeth Decoutere

CONTACT

+3211338411; liesbeth.decoutere@jessazh.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is not blinded (not for the patients participating in the trial and not for the treating physicians).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a subgroup of patients, a parallel study model will be used. In the group of patients with genotype "wild type" and phenotype "intermediate metabolizer", a comparison will be made between group A with dosage according to French guidelines and group B with dosage according to literature. After obtaining written informed consent, patients will be randomized in a 1:1 ratio to one of the two study groups.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 18, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share