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Norwegian Pancreatic Cancer Trial (NorPACT) - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919787
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : November 26, 2019
Sponsor:
Collaborators:
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 29, 2016
Last Update Posted Date November 26, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
Overall survival one year after resection [ Time Frame: 1 year ]
Overall survival at one year following commencement of allocated treatment for those who ultimately undergo resection (ie: only resected patients analyzed).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
  • Overall survival after date of randomization (intention to treat) [ Time Frame: 7 years ]
  • Feasibility of neoadjuvant and adjuvant chemotherapy (Common Terminology Criteria for Adverse Events, grade 3-5, dose reduction, dose delay) [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Norwegian Pancreatic Cancer Trial (NorPACT) - 1
Official Title  ICMJE Norwegian Pancreatic Cancer Trial (NorPACT) - 1: Norwegian Multicentre Un-blinded Phase III 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: 5-FU
    Neoadjuvant treatment
  • Drug: Oxaliplatine
    Neoadjuvant treatment
  • Drug: Irinotecan
    Neoadjuvant treatment
  • Procedure: Pancreatic surgery
    All patients
  • Drug: 5-FU
    Adjuvant treatment
  • Drug: Oxaliplatine
    Adjuvant treatment
  • Drug: Irinotecan
    Adjuvant treatment
Study Arms  ICMJE
  • Active Comparator: Surgery and then postoperative adjuvant chemotherapy
    Surgery and then postoperative adjuvant chemotherapy
    Interventions:
    • Procedure: Pancreatic surgery
    • Drug: 5-FU
    • Drug: Oxaliplatine
    • Drug: Irinotecan
  • Experimental: Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    Interventions:
    • Drug: 5-FU
    • Drug: Oxaliplatine
    • Drug: Irinotecan
    • Procedure: Pancreatic surgery
    • Drug: 5-FU
    • Drug: Oxaliplatine
    • Drug: Irinotecan
Publications * Labori KJ, Lassen K, Hoem D, Grønbech JE, Søreide 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Svein Dueland, MD, PhD 22934000 ext +47 svedue@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02919787
Other Study ID Numbers  ICMJE NorPACT-1
2015-001635-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Svein Dueland, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Helse Stavanger HF
  • Haukeland University Hospital
  • St. Olavs Hospital
  • University Hospital of North Norway
Investigators  ICMJE Not Provided
PRS Account Oslo University Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP