Pancreatic Cancer
Conditions
Keywords
Neoadjuvant treatment
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).
Interventions
DRUG5-FU
Neoadjuvant treatment
DRUGOxaliplatine
Neoadjuvant treatment
DRUGIrinotecan
Neoadjuvant treatment
PROCEDUREPancreatic surgery
All patients
Sponsors
St. Olavs Hospital
Haukeland University Hospital
University Hospital of North Norway
Sahlgrenska University Hospital
Karolinska University Hospital
University Hospital, Linkoeping
Lund University Hospital
Odense University Hospital
Helsinki University Hospital, Finland
Norrlands University Hospital
Helse Stavanger HF
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival 18 month after randomization | 18 month | Overall survival at 18 months after date of randomization (intention to treat) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | until 5 years after surgery | Patient will come to regular after surgery for follow-up visits regarding their disease. |
| 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) |
| Complication rate after surgery | 30 and 90 days | Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems |
| 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 |
| 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 |
Countries
Denmark, Finland, Norway, Sweden
Outcome results
None listed