Investigation of different biomarkers to predict response in pancreatic cancer patients, treated with FOLFIRINOX chemotherapy.
ID
Bron
Verkorte titel
Aandoening
Pancreatic cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Differences in SNPs, ctDNA (mutations), circulating miRNA, oral microbiome and immune profiles between responders and nonresponders to FOLFIRINOX chemotherapy.
Achtergrond van het onderzoek
FOLFIRINOX chemotherapy (a combination of folinic acid/Leucovorin, Fluorouracil, Irinotecan and Oxaliplatin) is the best treatment and the standard of care for patients with locally advanced or metastatic pancreatic cancer. However, only 30% of patients show response to treatment and more than 60% of all treated patients will experience a grade 3 or 4 adverse event caused by toxicity of the chemotherapy. At this moment, there are no biomarkers available which can predict response to FOLFIRINOX chemotherapy. Adequate selection of patients, preferably based on the use of a validated biomarker from peripheral blood sampling, will prevent unnecessary deterioration of their quality of life and reduce health care costs substantially.
The aim of this study is to investigate whether there are differences in several biomarkers (e.g. microRNAs or circulating tumor DNA) between responders and non-responders to FOLFIRINOX chemotherapy and between patients who experience severe toxicity and patients who do not experience severe toxicity due to FOLFIRINOX chemotherapy.
Doel van het onderzoek
Investigation of different biomarkers to predict response in pancreatic cancer patients, treated with FOLFIRINOX chemotherapy.
Onderzoeksopzet
Final analysis will take place 2 years after full inclusion.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age ≥ 18 years.
Diagnosed with (borderline) resectable, locally advanced or metastasized PDAC.
Treatment with FOLFIRINOX chemotherapy, including neoadjuvant and adjuvant therapy.
Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7522 |
| Ander register | METC Erasmus MC : MEC-2018-087 |