Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
140 participants
INTERVENTIONAL
2016-09-30
2026-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery and then postoperative adjuvant chemotherapy
Surgery and then postoperative adjuvant chemotherapy
Pancreatic surgery
All patients
5-FU
Adjuvant treatment
Oxaliplatine
Adjuvant treatment
Irinotecan
Adjuvant treatment
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
5-FU
Neoadjuvant treatment
Oxaliplatine
Neoadjuvant treatment
Irinotecan
Neoadjuvant treatment
Pancreatic surgery
All patients
5-FU
Adjuvant treatment
Oxaliplatine
Adjuvant treatment
Irinotecan
Adjuvant treatment
Interventions
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5-FU
Neoadjuvant treatment
Oxaliplatine
Neoadjuvant treatment
Irinotecan
Neoadjuvant treatment
Pancreatic surgery
All patients
5-FU
Adjuvant treatment
Oxaliplatine
Adjuvant treatment
Irinotecan
Adjuvant treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Haukeland University Hospital
OTHER
University Hospital of North Norway
OTHER
Sahlgrenska University Hospital
OTHER
Karolinska University Hospital
OTHER
University Hospital, Linkoeping
OTHER
Lund University Hospital
OTHER
Odense University Hospital
OTHER
Helsinki University Hospital, Finland
UNKNOWN
Norrlands University Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Oslo University Hospital
OTHER
Responsible Party
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Knut Jørgen Labori
Senior consultant surgeon, Professor of Surgery
Principal Investigators
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Knut Jorgen Labori, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Oslo University Hospital
Oslo, Oslo County, Norway
Haukeland University Hospital
Bergen, , 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
Countries
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References
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Labori KJ, Bratlie SO, Andersson B, Angelsen JH, Biorserud C, Bjornsson B, Bringeland EA, Elander N, Garresori H, Gronbech JE, Haux J, Hemmingsson O, Liljefors MG, Myklebust TA, Nymo LS, Peltola K, Pfeiffer P, Sallinen V, Sandstrom P, Sparrelid E, Stenvold H, Soreide K, Tingstedt B, Verbeke C, Ohlund D, Klint L, Dueland S, Lassen K; Nordic Pancreatic Cancer Trial-1 study group. Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):205-217. doi: 10.1016/S2468-1253(23)00405-3. Epub 2024 Jan 15.
Labori KJ, Lassen K, Hoem D, Gronbech JE, Soreide JA, Mortensen K, Smaaland R, Sorbye H, Verbeke C, Dueland S. Neoadjuvant chemotherapy versus surgery first for resectable pancreatic cancer (Norwegian Pancreatic Cancer Trial - 1 (NorPACT-1)) - study protocol for a national multicentre randomized controlled trial. BMC Surg. 2017 Aug 25;17(1):94. doi: 10.1186/s12893-017-0291-1.
Other Identifiers
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2015-001635-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NorPACT-1
Identifier Type: -
Identifier Source: org_study_id
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