No registrations found.
ID
Source
Brief title
Health condition
Pancreatic cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in SNPs, ctDNA (mutations), circulating miRNA, oral microbiome and immune profiles between responders and nonresponders to FOLFIRINOX chemotherapy.
Secondary outcome
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.
Background summary
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.
Study objective
Investigation of different biomarkers to predict response in pancreatic cancer patients, treated with FOLFIRINOX chemotherapy.
Study design
Final analysis will take place 2 years after full inclusion.
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7522 |
| Other | METC Erasmus MC : MEC-2018-087 |