Nordic Pancreatic Cancer Trial (NorPACT) - 1

University of Oslo (UIO)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Oxaliplatine; Procedure: Pancreatic surgery; Drug: Irinotecan; Drug: 5-FU

Study type: Interventional

Funder types: Other

Identifiers

NCT02919787

2015-001635-21 (EudraCT Number)

NorPACT-1

Details and patient eligibility

About

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

Full 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).

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Resectable adenocarcinoma of the pancreatic head
• T1-3, Nx, M0 (UICC 7th version, 2010)
• Cytologic or histologic confirmation of adenocarcinoma
• Age > 18 year and considered fit for major surgery
• Written informed consent
• Considered able to receive the study specific chemotherapy

Exclusion criteria

• Co-morbidity precluding pancreaticoduodenectomy
• Chronic neuropathy ≥ grade 2
• WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre
• Platelet count < 100 000 per cubic millimeter
• Serum creatinine > 1.5 UNL (upper limit normal range)
• Albumin < 2,5 g/dl
• Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
• Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
• Percutaneous tumor biopsy
• Any reason why, in the opinion of the investigator, the patient should not participate
• Pregnancy
• Breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Surgery and then postoperative adjuvant chemotherapy

Active Comparator group

Description:

Surgery and then postoperative adjuvant chemotherapy

Treatment:

Drug: 5-FU

Drug: Irinotecan

Procedure: Pancreatic surgery

Drug: Irinotecan

Drug: 5-FU

Drug: Oxaliplatine

Drug: Oxaliplatine

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

Experimental group

Description:

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

Treatment:

Drug: 5-FU

Drug: Irinotecan

Procedure: Pancreatic surgery

Drug: Irinotecan

Drug: 5-FU

Drug: Oxaliplatine

Drug: Oxaliplatine