NCT02919787

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

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
4 countries

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

6.3 years

First QC Date

September 14, 2016

Last Update Submit

November 18, 2024

Conditions

Pancreatic Cancer

Keywords

Neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

  • Overall survival 18 month after randomization

    Overall survival at 18 months after date of randomization (intention to treat)

    18 month

Secondary Outcomes (7)

  • Overall mortality at one year following commencement of allocated treatment.

    1 year

  • Disease-free survival

    until 5 years after surgery

  • Histopathological response

    Arm 1: Baseline and Arm 2; 4 weeks after baseline

  • Complication rate after surgery

    30 and 90 days

  • Feasibility of neoadjuvant and adjuvant chemotherapy

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

Surgery and then postoperative adjuvant chemotherapy

ACTIVE COMPARATOR

Surgery and then postoperative adjuvant chemotherapy

Procedure: Pancreatic surgeryDrug: 5-FUDrug: OxaliplatineDrug: Irinotecan

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

EXPERIMENTAL

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

Drug: 5-FUDrug: OxaliplatineDrug: IrinotecanProcedure: Pancreatic surgery

Interventions

5-FUDRUG

Neoadjuvant treatment

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
OxaliplatineDRUG

Neoadjuvant treatment

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
IrinotecanDRUG

Neoadjuvant treatment

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Pancreatic surgeryPROCEDURE

All patients

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapySurgery and then postoperative adjuvant chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Odense University Hospital

Odense, Denmark

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Oslo University Hospital

Oslo, Oslo County, N- 0424, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Stavanger University Hospital

Stavanger, 4011, Norway

Location

Tromsø University Hospital

Stavanger, 9038, Norway

Location

St. Olav University Hospital

Trondheim, 7030, Norway

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Karolinska University Hospital

Huddinge, 14157, Sweden

Location

Linköping University Hospital

Linköping, 58185, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

University Hospital of Umeå

Umeå, 90737, Sweden

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 38237621BACKGROUND

  • 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.

    PMID: 28841916DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

FluorouracilOxaliplatinIrinotecan

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesOrganic ChemicalsCamptothecinAlkaloids

Study Officials

  • Knut Jorgen Labori, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant surgeon, Professor of Surgery

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

December 22, 2022

Study Completion

April 30, 2026

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)FI(1)NO(5)SE(6)