A Study of Nal-IRI With 5-FU, Levofolinic Acid and Oxaliplatin in Patients With Resectable Pancreatic Cancer
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
Rational:Pancreatic cancer is a systemic disease at the time of diagnosis, even among
patients with apparent localized disease. Surgical resection is the only potentially curative
therapy for pancreatic cancer, but in patients who undergo surgery and postoperative therapy,
metastatic relapse remains common and no more than 20% of patients achieve 5-year survival.
Because of this aggressive biologic behavior, an increasing interest is growing about
preoperative treatments in resectable pancreatic cancer.
The combination chemotherapeutic regimen with irinotecan + 5-fluorouracil (5-FU)/leucovorin
(LV) + oxaliplatin (FOLFIRINOX) is an effective choice for first line treatment in patients
affected by advanced pancreatic cancer, and in this setting it achieved a Disease Control
Rate of 70.2 % (10). In this regard, FOLFIRINOX is currently explored as preoperative regimen
in a number of clinical trials in resectable pancreatic cancer.
A critical challenge in this field remains the introduction in these combination treatments
of the most novel and effective agents such as nalIRI, in order to obtain a more profound
tumor shrinkage, to increase the rate of R0 resections, to allow an early treatment of occult
micrometastatic disease, and eventually, to improve survival in patients with resectable
pancreatic cancer.
This study proposal is designed to address this challenge. Preliminary results, collected
during the Part 1 Dose Escalation of a current clinical trial performed in mPDAC, show that
dose of nal-IRI: 60 mg/m2, Oxaliplatin: 60 mg/m2, 5-FU/LV: 2400/400 mg/m2 is safe.