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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Haukeland University Hospital
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BergenNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Helse Stavanger HF
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StavangerNorwayRecruiting
Universitetssykehuset Nord-Norge HF
Coordinator of this site? Confirm its status
TromsoeNorwayRecruiting
St. Olavs hospital HF
Coordinator of this site? Confirm its status
TrondheimNorwayRecruiting
University of Gothenburg and Sahlgrenska University Hospital (SU)
Coordinator of this site? Confirm its status
GothenburgSwedenRecruiting
Karolinska University Hospital
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HuddingeSwedenRecruiting
Linköpings Universitet
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LinköpingSwedenRecruiting
Skåne University Hospital
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MalmöSwedenRecruiting
Norrlands universitetssjukhus
Coordinator of this site? Confirm its status
UmeåSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.