Clinical trial NCT02919787: Nordic Pancreatic Cancer Trial (NorPACT) - 1
Official title: Nordic Multicentre Un-blinded Phase II Randomized Controlled Trial (RCT) Evaluating the Additional Efficacy of Adding Chemotherapy Prior to Resection of a Pancreatic Head Malignancy to Avoid Early Mortality in Those Ultimately Resected
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pancreatic Cancer
Keywords: Neoadjuvant treatment
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Haukeland University Hospital
name: University Hospital of North Norway
name: Sahlgrenska University Hospital
name: Karolinska University Hospital
name: University Hospital, Linkoeping
name: Lund University Hospital
name: Odense University Hospital
name: Helsinki University Hospital, Finland
name: Norrlands University Hospital
name: Helse Stavanger HF
First posted: 2016-09-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival 18 month after randomization
timeFrame: 18 month
Secondary outcomes:
measure: Overall mortality at one year following commencement of allocated treatment.
timeFrame: 1 year
measure: Disease-free survival
timeFrame: until 5 years after surgery
measure: Histopathological response
timeFrame: Arm 1: Baseline and Arm 2; 4 weeks after baseline
measure: Complication rate after surgery
timeFrame: 30 and 90 days
measure: Feasibility of neoadjuvant and adjuvant chemotherapy
timeFrame: Baseline
measure: Health related Quality of Life
timeFrame: until 5 years after surgery
measure: Health economics
timeFrame: until 5 years after surgery
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Stavanger
country: Norway
facility: Tromsø University Hospital
city: Trondheim
country: Norway
facility: St. Olav University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Umeå
country: Sweden
facility: University Hospital of Umeå
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Knut Jorgen Labori, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.