The NORPACT-1 trial is a phase 2 clinical study that specifically enrolled patients with tumors located in the head of the pancreas. The trial focused on evaluating the effectiveness of a treatment approach known as neoadjuvant chemotherapy, specifically using the FOLFIRINOX regimen.
The purpose of neoadjuvant chemotherapy is to administer chemotherapy prior to surgery with the aim of reducing tumor size and potentially increasing the chances of successful surgical removal (resection). This approach is commonly used in various cancers, including pancreatic cancer, to improve outcomes.
In the NORPACT-1 trial, the researchers investigated whether giving neoadjuvant FOLFIRINOX chemotherapy for four out of twelve cycles would improve overall survival (OS) compared to proceeding directly to upfront surgery without any preoperative chemotherapy. The FOLFIRINOX regimen is a combination chemotherapy regimen consisting of four drugs: 5-fluorouracil (5-FU), leucovorin, irinotecan, and oxaliplatin.
The trial specifically enrolled patients with (1.) resectable tumors, meaning their tumors were deemed surgically removable without evidence of extensive local invasion or metastasis. Patients with borderline resectable tumors, where surgery may be challenging due to involvement of adjacent structures, were not included in this trial. This is a phase 2 study and results were from patients with pancreatic head cancer tumor.
The results of the NORPACT-1 trial indicated that giving neoadjuvant FOLFIRINOX chemotherapy for four cycles before surgery did not improve overall survival when compared to upfront surgery. This means that there was no significant difference in survival outcomes between the two treatment approaches. Further studies are needed to understand better the treatment approach in this setting.
