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Nordic 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919787
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Last Update Posted : February 10, 2023
Sponsor:
Collaborators:
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Knut Jørgen Labori, Oslo University Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: 5-FU Drug: Oxaliplatine Drug: Irinotecan Procedure: Pancreatic surgery Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Actual Primary Completion Date : December 22, 2022
Estimated Study Completion Date : April 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Surgery and then postoperative adjuvant chemotherapy
Surgery and then postoperative adjuvant chemotherapy
 Procedure: Pancreatic surgery
All patients

Drug: 5-FU
Adjuvant treatment

Drug: Oxaliplatine
Adjuvant treatment

Drug: Irinotecan
Adjuvant treatment
Experimental: Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
 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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival 18 month after randomization [ Time Frame: 18 month ]
    Overall survival at 18 months after date of randomization (intention to treat)


Secondary Outcome Measures :
  1. Overall mortality at one year following commencement of allocated treatment. [ Time Frame: 1 year ]
    Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection

  2. Disease-free survival [ Time Frame: until 5 years after surgery ]
    Patient will come to regular after surgery for follow-up visits regarding their disease.

  3. Histopathological response [ Time Frame: Arm 1: Baseline and Arm 2; 4 weeks after baseline ]
    The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)

  4. Complication rate after surgery [ Time Frame: 30 and 90 days ]
    Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems

  5. Feasibility of neoadjuvant and adjuvant chemotherapy [ Time Frame: Baseline ]
    The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay

  6. Health related Quality of Life [ Time Frame: until 5 years after surgery ]
    Data of quality of life will be assessed by the questionnaires EORTC QLQ-30

  7. Health economics [ Time Frame: until 5 years after surgery ]
    Data of quality of life will be assessed by the questionnaires EQ-5D


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919787


Locations
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Denmark
Per Pfeiffer
Odense, Denmark
Finland
Ville Sallinen
Helsinki, Finland, 00029
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Oslo University Hospital
Oslo, Norway, N- 0424
Stavanger University Hospital
Stavanger, Norway, 4011
Tromsø University Hospital
Stavanger, Norway, 9038
St. Olav University Hospital
Trondheim, Norway, 7030
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Karolinska University Hospital
Huddinge, Sweden, 14157
Linköping University Hospital
Linköping, Sweden, 58185
Skåne University Hospital
Lund, Sweden
University Hospital of Umeå
Umeå, Sweden, 90737
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Oslo University Hospital
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Investigators
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Principal Investigator: Knut Jorgen Labori, MD PhD Oslo University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Knut Jørgen Labori, Senior Consultant HPB-surgery, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02919787    
Other Study ID Numbers: NorPACT-1
2015-001635-21 ( EudraCT Number )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Knut Jørgen Labori, Oslo University Hospital:
Neoadjuvant treatment
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Irinotecan
Fluorouracil
Oxaliplatin
 Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs