Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)

November 18, 2024 updated by: Knut Jørgen Labori, Oslo University Hospital

Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - a Norwegian Population Based Observational Study (NORPACT-2)

This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0268
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Population based cohort from a universal health care system

Description

Inclusion Criteria:

  • borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)
  • Nx, M0 (UICC 8 th version, 2016)
  • cytological or histological 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 pancreatectomy
  • chronic neuropathy ≥ grade 2
  • WHO performance score > 2
  • granulocyte count < 1500 per cubic millimetre
  • platelet count < 100 000 per cubic millimetre
  • 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 physical disorders that could interfere with treatment of with the provision of informed consent
  • any reason why, in the opinion of the investigator, the patient should not participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
Time Frame: 5 years
Patients who undergo surgical resection will be documented
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival from time of inclusion (intention to treat)
Time Frame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
Overall survival rate at 5 years using Kaplan-Meier survival analysis
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 1 year after inclusion
1 year after inclusion
Overall survival following resection
Time Frame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
Overall survival rate at 5 years using Kaplan-Meier survival analysis
Overall survival after 1, 2, 3 and 5 years
Time Frame: 1, 2, 3 and 5 years after inclusion
1, 2, 3 and 5 years after inclusion
1-year progression-free survival rate
Time Frame: 1-year after surgical resection
1-year after surgical resection
Disease-free survival
Time Frame: Disease-free survival at 5 years using Kaplan-Meier survival analysis
Disease-free survival at 5 years using Kaplan-Meier survival analysis
Radiological response
Time Frame: 2-6 months after initiation of chemotherapy
2-6 months after initiation of chemotherapy
Histopathological response
Time Frame: 14-30 days post surgery
14-30 days post surgery
R0 resection rate
Time Frame: 14-30 days post surgery
14-30 days post surgery
Complication rates after surgery classification systems)
Time Frame: 30 and 90 days post surgery
Dindo-Clavien and ISPGS
30 and 90 days post surgery
Completion rates of all parts of multimodal treatment
Time Frame: Up to 1 year after inclusion
Up to 1 year after inclusion
QoL (EORTC QLQ-30)
Time Frame: 5 years
5 years
Performance status - Eastern Cooperative Oncology Group (ECOG)
Time Frame: 5 years

0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)

  1. - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
  2. - Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
  3. - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
  4. - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University Hospital of North Norway
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital

Investigators

  • Principal Investigator: Knut J. Labori, MD, PhD, Oslo University Hospital, Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 31, 2022

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/1382/REK nord

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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