To investigate whether there are differences in single nucleotide polymorphism*s (SNPs), circulating tumor DNA (ctDNA), micro RNA (miRNA) and immune profiles between responders and non-responders to FOLFIRINOX chemotherapy and between patients who…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in expression between responders and non-responders and between
patients who experience severe toxicity and those who do not, based on:
* SNPs
* ctDNA mutations
* miRNA patterns
* Microbiome patterns
* Immune profiles
Secondary outcome
* Response rate
* Number of adverse events
* Resection rate
* Progression free survival
* Overall survival.
Background summary
Pancreatic cancer has a very high mortality rate, partially because of
diagnosis at late stage of disease. Only 20% of patients present with
resectable disease. For all other patients FOLFIRINOX chemotherapy (a
combination of Oxaliplatin, Leucovorin, Irinotecan and Fluorouracil) is the
best treatment and the standard of care. 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. Previous studies have shown that certain single nucleotide
polymorphisms (SNP*s) are associated with chemotherapy resistance. Changes in
circulating tumor DNA and micro RNAs are thought to be of great value in
indicating therapy response. Besides that, certain immune profiles may relate
to different therapy responses, as described for other tumors.
Study objective
To investigate whether there are differences in single nucleotide
polymorphism*s (SNPs), circulating tumor DNA (ctDNA), micro RNA (miRNA) and
immune profiles 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 design
Prospective multicenter cohort study. 200 patients will be included over a
period of 2 years. Blood samples will be drawn at two time points: before the
first cycle and before the second cycle of FOLFIRINOX. After 4 cycles of
FOLFIRINOX a CT scan will be performed to evaluate progression of disease.
Intervention
The intervention consists of 2 additional blood draws during a standard visit
to the outpatient clinic. During each visit 5 additional tubes of blood (43 ml)
will be collected.
Study burden and risks
Risks
Besides the slight chance of pain or bruising during the blood collection there
are considered to be no extra risks in participating in this study.
Benefit
We expect that in the future patients diagnosed with pancreatic cancer can
benefit from the results of this research.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
* Age * 18 years
* Diagnosed with (borderline) resectable, locally advanced or metastasized pancreatic cancer
* 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
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 |
|---|---|
| CCMO | NL65025.078.18 |