NCT02919787

Nordic Pancreatic Cancer Trial (NorPACT) - 1

Nordic Multicentre Un-blinded Phase II Randomized Controlled Trial (RCT) Evaluating the Additional Efficacy of Adding Chemotherapy Prior to Resection of a Pancreatic Head Malignancy to Avoid Early Mortality in Those Ultimately Resected

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

Detailed description

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC). Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear. The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	5-FU	Neoadjuvant treatment
DRUG	Oxaliplatine	Neoadjuvant treatment
DRUG	Irinotecan	Neoadjuvant treatment
PROCEDURE	Pancreatic surgery	All patients
DRUG	5-FU	Adjuvant treatment
DRUG	Oxaliplatine	Adjuvant treatment
DRUG	Irinotecan	Adjuvant treatment

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-12-22
• Completion: 2026-04-30
• First posted: 2016-09-29
• Last updated: 2024-11-20

Locations

13 sites across 4 countries: Denmark, Finland, Norway, Sweden