Nordic Pancreatic Cancer Trial (NorPACT) - 1

Phase 3Active Not RecruitingNCT02919787

Oslo University Hospital140 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Pancreatic Cancer

Interventions

5-FUDRUG

Neoadjuvant treatment

OxaliplatineDRUG

Neoadjuvant treatment

IrinotecanDRUG

Neoadjuvant treatment

Pancreatic surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Odense University Hospital

Odense, Denmark

Helsinki University Hospital

Helsinki, Finland

Oslo University Hospital

Oslo, Oslo, Norway

Outcomes

Primary Outcomes

Overall survival 18 month after randomization

Overall survival at 18 months after date of randomization (intention to treat)

Time frame: 18 month

Secondary Outcomes

Overall mortality at one year following commencement of allocated treatment.

Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection

Time frame: 1 year

Disease-free survival

Patient will come to regular after surgery for follow-up visits regarding their disease.

Time frame: until 5 years after surgery

Histopathological response

The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)

Time frame: Arm 1: Baseline and Arm 2; 4 weeks after baseline

Complication rate after surgery

Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems

Time frame: 30 and 90 days

Feasibility of neoadjuvant and adjuvant chemotherapy

The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay

Time frame: Baseline

Health related Quality of Life

Data of quality of life will be assessed by the questionnaires EORTC QLQ-30

Time frame: until 5 years after surgery

Data from ClinicalTrials.gov

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