Nordic Pancreatic Cancer Trial (NorPACT) - 1
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT02919787
- Lead Sponsor
- Oslo University Hospital
- Brief 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery and then postoperative adjuvant chemotherapy Oxaliplatine Surgery and then postoperative adjuvant chemotherapy Surgery and then postoperative adjuvant chemotherapy Pancreatic surgery Surgery and then postoperative adjuvant chemotherapy Surgery and then postoperative adjuvant chemotherapy 5-FU Surgery and then postoperative adjuvant chemotherapy Surgery and then postoperative adjuvant chemotherapy Irinotecan Surgery and then postoperative adjuvant chemotherapy Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Pancreatic surgery Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy 5-FU Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Oxaliplatine Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Irinotecan Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
- Primary Outcome Measures
Name Time Method Overall survival 18 month after randomization 18 month Overall survival at 18 months after date of randomization (intention to treat)
- Secondary Outcome Measures
Name Time Method Overall mortality at one year following commencement of allocated treatment. 1 year Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection
Histopathological response Arm 1: Baseline and Arm 2; 4 weeks after baseline The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)
Disease-free survival until 5 years after surgery Patient will come to regular after surgery for follow-up visits regarding their disease.
Complication rate after surgery 30 and 90 days Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems
Health related Quality of Life until 5 years after surgery Data of quality of life will be assessed by the questionnaires EORTC QLQ-30
Health economics until 5 years after surgery Data of quality of life will be assessed by the questionnaires EQ-5D
Feasibility of neoadjuvant and adjuvant chemotherapy Baseline The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay
Trial Locations
- Locations (13)
Odense University Hospital
🇩🇰Odense, Denmark
Helsinki University Hospital
🇫🇮Helsinki, Finland
Haukeland University Hospital
🇳🇴Bergen, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
Stavanger University Hospital
🇳🇴Stavanger, Norway
Tromsø University Hospital
🇳🇴Stavanger, Norway
St. Olav University Hospital
🇳🇴Trondheim, Norway
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Karolinska University Hospital
🇸🇪Huddinge, Sweden
Linköping University Hospital
🇸🇪Linköping, Sweden
Skåne University Hospital
🇸🇪Lund, Sweden
University Hospital of Umeå
🇸🇪Umeå, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden