Predictieve biomarkers voor FOLFIRINOX respons in patiënten met alvleesklierkanker

New biomarkers for prediction of response to FOLFIRINOX chemotherapy in pancreatic cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29299

Enrollment

200

Registered

2019-02-14

Start date

2018-02-13

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: ? Age = 18 years. ? Diagnosed with (borderline) resectable, locally advanced or metastasized PDAC. ? Treatment with FOLFIRINOX chemotherapy, including neoadjuvant and adjuvant therapy. ? Written informed consent

Exclusion criteria

Exclusion criteria: ? Combined treatment with other chemotherapeutics then FOLFIRINOX. ? Previous treatment with FOLFIRINOX chemotherapy. ? Pregnancy. ? Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Design outcomes

Primary

Measure	Time frame
Differences in SNPs, ctDNA (mutations), circulating miRNA, oral microbiome and immune profiles between responders and nonresponders to FOLFIRINOX chemotherapy.	—

Secondary

Measure	Time frame
Differences in SNPs, ctDNA (mutations), circulating miRNA, oral microbiome and immune profiles between patients who experience severe (grade 3 or 4) toxicity and patients who do not experience severe toxicity due to FOLFIRINOX treatment. Also: response rate, number of adverse events, resection rate, progression free survival, overall survival.	—

Contacts

Public ContactFleur van der Sijde

Erasmus University Medical Center

f.vandersijde@erasmusmc.nl0642101567

Outcome results