NCT02919787RecruitingPhase 2
Nordic Pancreatic Cancer Trial (NORPACT) – 1
Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer : a multicentre, randomised, phase 2 trial (Nordic Pancreatic Cancer Trial (NORPACT) – 1
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to assess the additional value of neoadjuvant chemotherapy to the standard treatment (surgery + adjuvant chemotherapy) for resectable cancer of the pancreatic head as a means of avoiding early mortality and improve overall survival.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 131 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 1 Feb 2017
- Lead sponsor
- Oslo University Hospital HF
- Diseases
- Pancreatic cancer
- NCT number
- NCT02919787
- EU CT number
- 2024-517719-65-00
- EudraCT number
- 2015-001635-21
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 131
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
Other illness
- 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
Lab values
- Granulocyte count < 1500 per cubic millimetre (< 1,5 x 109/L)
- Platelet count < 100 000 per cubic millimetre (< 100 x 109/L)
- Serum creatinine > 1.5 UNL (upper limit normal range)
- Albumin < 2,5 g/dl (< 25 g/L)
Age
- Female patients in child bearing age not using adequate contraception, pregnant or lactating women
Other
- Co-morbidity precluding pancreatoduodenectomy
- Percutaneous tumor biopsy
- Any reason why, in the opinion of the investigator, the patient should not participate
- Chronic neuropathy ≥ grade 2
- WHO performance score ≥ 2
Who the study is looking for
- Resectable tumour of the pancreatic head radiologically strongly suspect of pancreatic adenocarcinoma
- T1-3, Nx, M0 (UICC 7th version, 2010)
- Age > 18 year and considered fit for major surgery
- Written informed consent
- Considered able to receive the study specific chemotherapy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| University of Gothenburg and Sahlgrenska University Hospital (SU) Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Recruiting |
| Linköpings Universitet Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
| Norrlands universitetssjukhus Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.