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ID
Source
Brief title
Health condition
Pancreatic cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in circulating tumor DNA, microRNAs, SNPs, and cytokines between patients with disease control and patients with progressive disease during FOLFIRINOX treatment and sensitivity and specificity of these biomarkers.
Secondary outcome
N/A
Background summary
Pancreatic ductal adenocarcinoma (PDAC) has a very high mortality rate, partially because of diagnosis at late stage of disease. Only 20% of patients present with resectable disease. Nowadays, the standard first-line treatment for locally advanced (LAPC) and metastatic PDAC is FOLFIRINOX chemotherapy, a combination of fluorouracil, leucovorin, irinotecan and oxaliplatin. Despite increased overall survival in FOLFIRINOX-treated patient groups, 20-30% of patients will already show progressive disease during chemotherapy treatment. In the meantime, 60-70% of patients experiences grade 3-5 toxicity from FOLFIRINOX treatment. Biomarkers, especially those that can be easily measured in the peripheral blood instead of tumor tissue, are necessary to stratify patients for available therapies. Being able to select only patients that will benefit from FOLFIRINOX chemotherapy could prevent non-responding patients from severe FOLFIRINOX-induced toxicity. These nonresponders might benefit from other types of (chemo)therapy instead. In a previous pilot study (iKnowIT), we found some promising candidate biomarkers, measured in the peripheral blood of PDAC patients, that might predict FOLFIRINOX response.
The aim of this study is to validate promising circulating predictive biomarkers for FOLFIRINOX response in patients with PDAC, including circulating tumor DNA mutations, microRNAs, single nucleotide polymorphisms (SNPs) and cytokines, and to generate a biobank of blood samples to investigate future biomarkers.
Study objective
Validation of previously found predictive biomarkers for FOLFIRINOX response
Study design
Differences in ctDNA, miRNAs, SNPs, and cytokines will be measured in blood samples drawn before start of the first cycle of FOLFIRINOX and before start of the second cycle of FOLFIRINOX. Patients will be grouped according to the RECIST chemotherapy response: disease control or progressive disease. These results are available from the final response evaluation after 8 cycles of FOLFIRINOX.
Final analysis on all data, including patient characteristics, survival outcome, response outcome, and biomarker data will take place 2.5 years after full inclusion. After 2.5 years response outcome will be available for all patients.
Inclusion criteria
• Age ≥ 18 years.
• Diagnosed with (borderline) resectable, locally advanced or metastatic PDAC.
• Treatment with FOLFIRINOX chemotherapy, including neoadjuvant therapy in the investigational group ór treatment with gemcitabine (with nab-paclitaxel) in the control group.
• Written informed consent (either for PANCAKE in case of locally advanced PDAC and metastasized PDAC or for the PREOPANC-3 trial in case of (borderline) resectable PDAC).
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 | NL9609 |
| Other | METC Erasmus MC : MEC-2021-0001 |