A Study to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer (TRUST)

September 12, 2019 updated by: Celgene

Non-interventional Observational Post-authorization Study to Assess Clinical and Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Routine Clinical Practice Treating Pancreatic Cancer (TRUST)

The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.

Study Overview

Status

Terminated

Conditions

Detailed Description

The TRUST, a prospective, non-interventional observational single arm study with Nab-paclitaxel + Gemcitabine (NG) in pancreas carcinoma in the Netherlands, was started in 2015 to observe and register the daily use of Nab-paclitaxel. The primary objective was to prospectively assess safety of NG in metastatic pancreatic cancer under routine clinical practice. One of the major secondary objectives was to assess the influence of treatment with Nab-paclitaxel + Gemcitabine on the quality of life. The goal was to include 200 patients within a period of two year and collect their prospective data.

The study has included 44 patients in the period between October 2015 and October 2017. Of these patients, 41% were diagnosed with metastasized disease. 54% was diagnosed with local disease of which 18% was resectable and 36% was locally advanced. 73% of the patients with metastasized disease were treated with NG.

Over 70% of all NG treated patients received this treatment as a fist line of care. 21% of these patients had locally advanced pancreatic cancer. 20% of the patients had had a previous systemic treatment. Of all NG treated patients, 66% had an ECOG performance status of 0 or 1 and 62% of the patients was 75 years or younger.

At the time the study was terminated, 6 out of the 44 patients were still treated. 14 patients had stopped treatment due to disease progression, 8 patients had stopped due to adverse events and 7 patients had chosen to stop treatment.

The low inclusion rate, which led to a prospective study duration of 10 years, and the heterogenicity of the study population have led to the decision to terminate the study. Therefore, no analysis, apart from the detailed description of the study population above, can be performed.

All patients involved have taken the time to participate in the study and have filled out questionnaires. We would like to express our gratitude towards these patients.

We remain convinced that quality of life is an important parameter in pancreatic cancer which should be taken into consideration in daily care of patients.

Study Type

Observational

Enrollment (Actual)

44

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

  • Netherlands
      • Groningen, Netherlands, 9728 NT
        • Martini Ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
    • Friesland
      • Heerenveen, Friesland, Netherlands, 8841 PW
        • Ziekenhuis De Tjongerschans
      • Sneek, Friesland, Netherlands, 8601 ZK
        • Antonius Ziekenhuis Sneek
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 A
        • Rijnstate Ziekenhuis
      • Breda, Gelderland, Netherlands, 4818 CK
        • Amphia Ziekenhuis
    • North Brabant
      • Ede, North Brabant, Netherlands, 2545 CH
        • Gelderse Vallei
      • Helmond, North Brabant, Netherlands, 5707 HA
        • Elkerliek Ziekenhuis
    • North Holland
      • Haarlem, North Holland, Netherlands, 2035 RC
        • Spaarne Gasthuis
      • Hilversum, North Holland, Netherlands, 1213XZ
        • Tergooi
    • North- Holland
      • Amsterdam, North- Holland, Netherlands, 1034 CS
        • BovenIJ ziekenhuis
      • Amsterdam, North- Holland, Netherlands, 1105 AZ
        • Academic Medical Centre
    • North-Brabant
      • Veldhoven, North-Brabant, Netherlands, 5504 DB
        • Maxima Medisch Centrum
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Isala
    • South- Holland
      • The Hague, South- Holland, Netherlands, 2545 CH
        • Hagaziekenhuis
    • South-Holland
      • Dordrecht, South-Holland, Netherlands, 3328 AT
        • Albert Schweitzer Ziekenhuis
      • Leiden, South-Holland, Netherlands, 2333 ZA
        • LUMC
    • Zeeland
      • Terneuzen, Zeeland, Netherlands, 4535 PA
        • Zorgsaam Zeeuws -Vlaanderen

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two-hundred adult patients treated with the combination nab-paclitaxel and gemcitabine (AG) for metastatic pancreatic adenocarcinoma will be recruited from approximately 25 oncology sites in the Netherlands. In all cases, the decision to treat the patient with AG was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per SmPC.

Description

Inclusion Criteria:

  • Patients over 18 years of age who understand and voluntarily sign an informed consent form.
  • Patients treated for pancreatic adenocarcinoma.

Exclusion Criteria:

  • Patients currently treated for metastatic pancreatic cancer with other therapy than nab-paclitaxel plus gemcitabine
  • Refusal to participate in the study.
  • Women who are pregnant or breast-feeding.
  • Hypersensitivity to the active substance or to any of the excipients.
  • Participation in interventional trials during the period of treatment with nab-paclitaxel

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

Cohorts and Interventions

Group / Cohort
Nab-paclitaxel in combination with gemcitabine (AG)
The objective is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma. In all cases, the decision to treat the patient with nab-paclitaxel in combination with gemcitabine was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per Summary of Product Characteristics (SPC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to approximately 3 years
Survival is defined as the time from the first dose of nab-paclitaxel in combination with gemcitabine date to the date of death (any cause).
Up to approximately 3 years
Adverse Event (AE)
Time Frame: Up to approximately 3 years
Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible.
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the EORTC-QLQ-CIPN-20 (European Organization for Research and Treatment of Cancer Quality of Life Instrument In Patients With Chemotherapy Induced Peripheral Neuropathy )
Time Frame: up to approximately 3 years
The instrument contains 20 questions evaluating sensory, motor, and autonomic symptoms, and has been validated as an assessment tool for CIPN. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
up to approximately 3 years
Change from baseline in the EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Instrument)
Time Frame: up to approximately 3 years
The instrument contains 30 questions evaluating quality of life in cancer patients.
up to approximately 3 years
Change from baseline in the EuroQuality of Life : EQ5D-3L
Time Frame: up to approximately 3 years
A generic Quality of Life (QOL) instrument to measure and evaluate health status outcomes. The 3 Level (3L) version describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem).
up to approximately 3 years
Evaluate the incidence of neuropathy - grade 1-5
Time Frame: up to approximately 3 years
Descriptive analysis of incidence and severity of neuropathy according to physicians assessment
up to approximately 3 years
Evaluate reversibility of neuropathy to Gr ≤1
Time Frame: up to approximately 3 years
The time to decrease of neuropathy to Gr ≤1 using the NCI CTCAE grading scale.
up to approximately 3 years
Evaluate the resources utilized for treatment of pancreatic adenocarcinoma with the combination nab-paclitaxel/gemcitabine in routine clinical practice
Time Frame: up to approximately 3 years
Per hospital, one generalized questionnaire will be filled in to evaluate the use of utilized resources when treating metastatic pancreatic cancer within routine clinical practice.
up to approximately 3 years

Collaborators and Investigators

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

Sponsor

Celgene

Investigators

  • Study Director: Jeroen Stevens, Msc, Celgene Corporation

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)

October 1, 2015

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI-007-PANC-008

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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