search
Back to results

Nordic Pancreatic Cancer Trial (NorPACT) - 1

Primary Purpose

Pancreatic Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
5-FU
Oxaliplatine
Irinotecan
Pancreatic surgery
5-FU
Oxaliplatine
Irinotecan
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Neoadjuvant treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Per Pfeiffer
  • Ville Sallinen
  • Haukeland University Hospital
  • Oslo University Hospital
  • Stavanger University Hospital
  • Tromsø University Hospital
  • St. Olav University Hospital
  • Sahlgrenska University Hospital
  • Karolinska University Hospital
  • Linköping University Hospital
  • Skåne University Hospital
  • University Hospital of Umeå
  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery and then postoperative adjuvant chemotherapy

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

Arm Description

Surgery and then postoperative adjuvant chemotherapy

Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall mortality at one year following commencement of allocated treatment.
Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection
Disease-free survival
Patient will come to regular after surgery for follow-up visits regarding their disease.
Histopathological response
The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)
Complication rate after surgery
Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems
Feasibility of neoadjuvant and adjuvant chemotherapy
The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay
Health related Quality of Life
Data of quality of life will be assessed by the questionnaires EORTC QLQ-30
Health economics
Data of quality of life will be assessed by the questionnaires EQ-5D

Full Information

First Posted
September 14, 2016
Last Updated
February 9, 2023
Sponsor
Oslo University Hospital
Collaborators
Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
search

1. Study Identification

Unique Protocol Identification Number
NCT02919787
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Neoadjuvant treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery and then postoperative adjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
Surgery and then postoperative adjuvant chemotherapy
Arm Title
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Neoadjuvant treatment
Intervention Type
Drug
Intervention Name(s)
Oxaliplatine
Intervention Description
Neoadjuvant treatment
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Neoadjuvant treatment
Intervention Type
Procedure
Intervention Name(s)
Pancreatic surgery
Intervention Description
All patients
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Adjuvant treatment
Intervention Type
Drug
Intervention Name(s)
Oxaliplatine
Intervention Description
Adjuvant treatment
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Adjuvant treatment
Primary Outcome Measure Information:
Title
Overall survival 18 month after randomization
Description
Overall survival at 18 months after date of randomization (intention to treat)
Time Frame
18 month
Secondary Outcome Measure Information:
Title
Overall mortality at one year following commencement of allocated treatment.
Description
Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection
Time Frame
1 year
Title
Disease-free survival
Description
Patient will come to regular after surgery for follow-up visits regarding their disease.
Time Frame
until 5 years after surgery
Title
Histopathological response
Description
The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)
Time Frame
Arm 1: Baseline and Arm 2; 4 weeks after baseline
Title
Complication rate after surgery
Description
Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems
Time Frame
30 and 90 days
Title
Feasibility of neoadjuvant and adjuvant chemotherapy
Description
The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay
Time Frame
Baseline
Title
Health related Quality of Life
Description
Data of quality of life will be assessed by the questionnaires EORTC QLQ-30
Time Frame
until 5 years after surgery
Title
Health economics
Description
Data of quality of life will be assessed by the questionnaires EQ-5D
Time Frame
until 5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Jorgen Labori, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Per Pfeiffer
City
Odense
Country
Denmark
Facility Name
Ville Sallinen
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N- 0424
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Tromsø University Hospital
City
Stavanger
ZIP/Postal Code
9038
Country
Norway
Facility Name
St. Olav University Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska University Hospital
City
Huddinge
ZIP/Postal Code
14157
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Skåne University Hospital
City
Lund
Country
Sweden
Facility Name
University Hospital of Umeå
City
Umeå
ZIP/Postal Code
90737
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28841916
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.
Results Reference
derived

Learn more about this trial

Nordic Pancreatic Cancer Trial (NorPACT) - 1

We'll reach out to this number within 24 hrs