Pancreatic cancer has an unfavorable prognosis with a reduced possibility of long-term survival. The only treatment with curative potential is surgery, but it is only possible in 15-20% of cases. There are patients with clear criteria for surgical entry, others at the limit of the possibility of surgery, and patients with such advanced disease (either locally or with metastasis) that surgery is not indicated. The objective of neoadjuvant chemotherapy treatment (received before surgery) is to reduce the tumor before surgery and reduce the risk of subsequent metastases and local recurrences, in borderline tumors or those resectable with high-risk criteria. The FOLFIRINOX scheme, composed of 5-fluorouracil / folinic acid, oxaliplatin and irinotecan, is recommended as neoadjuvant treatment, but the response is still low. This study will use a modified FOLFIRINOX (NALIRINOX) regimen with a form of irinotecan attached to liposomes that allows greater action on tumor cells. Mutations in the KRAS gene are associated with a greater growth capacity of tumor cells and are present in 90% of pancreatic cancers in advanced stages. They would be less frequent in earlier phases but little is known about the impact that chemotherapy treatment and subsequent surgery could have on the increase or decrease of these mutations, as well as their implication. The follow-up of these mutations with repeated pancreatic biopsies is not viable, but it can be monitored by simple blood samples in which the genetic material of the tumor can be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
NALRINOX: combination of three chemotherapy agents: 5- FU/LV, nal-IRI, and oxaliplatin
Hestia Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Madrid Sanchinarro
PAU de Sanchinarro, Madrid, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Proportion of subjects with a good histological tumour response in the resected specimens after neoadjuvant chemotherapy with NALIRINOX and surgical removal according to the Ryan's classification in KRAS positive and negative patients
Time frame: 8 weeks after surgical intervention
R0 resection
Time frame: Through the study completion (estimated to be 15 months)
1-year survival and Overal survival (OS) in baseline KRAS+ and KRAS- subjects
Time frame: Through the study completion (estimated to be 15 months)
Progression Free Survival (PFS)
Time frame: Through the study completion (estimated to be 15 months)
Assessment of the proportion of KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Assessment of the number of KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Impact on R0 resection for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Impact on histological tumour response for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Impact on PFS for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Impact on 1-year survival for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Impact on OS for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX
Time frame: Through the study completion (estimated to be 15 months)
Number of AEs and SAEs (according to CTCAE) to describe the safety profile of the neoadjuvant NALIRINOX scheme
Time frame: Through the study completion (estimated to be 15 months)
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