- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2016-09
2022-12-22
2026-04-30
140
NCT02919787
Oslo University Hospital
Oslo University Hospital
INTERVENTIONAL
Nordic Pancreatic Cancer Trial (NorPACT) - 1
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-09-14 | N/A | 2024-11-18 |
2016-09-28 | N/A | 2024-11-20 |
2016-09-29 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Surgery and then postoperative adjuvant chemotherapy Surgery and then postoperative adjuvant chemotherapy | PROCEDURE: Pancreatic surgery
DRUG: 5-FU
DRUG: Oxaliplatine
DRUG: Irinotecan
|
| EXPERIMENTAL: Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy | DRUG: 5-FU
DRUG: Oxaliplatine
DRUG: Irinotecan
PROCEDURE: Pancreatic surgery
DRUG: 5-FU
DRUG: Oxaliplatine
DRUG: Irinotecan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival 18 month after randomization | Overall survival at 18 months after date of randomization (intention to treat) | 18 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Disease-free survival | Patient will come to regular after surgery for follow-up visits regarding their disease. | 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) | 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 | 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 | Baseline |
| Health related Quality of Life | Data of quality of life will be assessed by the questionnaires EORTC QLQ-30 | until 5 years after surgery |
| Health economics | Data of quality of life will be assessed by the questionnaires EQ-5D | until 5 years after surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
