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

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ClinicalTrials.gov Identifier: NCT02670746
Recruitment Status : Terminated (Due to slow recruitment study is being terminated.)
First Posted : February 2, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
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.

Condition or disease
Pancreatic Neoplasms

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).



Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT02670746


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

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02670746     History of Changes
Other Study ID Numbers: ABI-007-PANC-008
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Celgene:
Pancreatic Cancer
Observational
Nab-Paclitaxel
Abraxane
ABI-007
Gemcitabine
Non-interventional
Netherlands
Quality of Life

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs