Clinical trial NCT02670746: A Study to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic Cancer
Observational
Nab-Paclitaxel
Abraxane
ABI-007
Gemcitabine
Non-interventional
Netherlands
Quality of Life
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: Up to approximately 3 years
measure: Adverse Event (AE)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: 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 )
timeFrame: up to approximately 3 years
measure: Change from baseline in the EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Instrument)
timeFrame: up to approximately 3 years
measure: Change from baseline in the EuroQuality of Life : EQ5D-3L
timeFrame: up to approximately 3 years
measure: Evaluate the incidence of neuropathy - grade 1-5
timeFrame: up to approximately 3 years
measure: Evaluate reversibility of neuropathy to Gr ≤1
timeFrame: up to approximately 3 years
measure: Evaluate the resources utilized for treatment of pancreatic adenocarcinoma with the combination nab-paclitaxel/gemcitabine in routine clinical practice
timeFrame: up to approximately 3 years
Other outcomes:
Locations:
city: Heerenveen
country: Netherlands
facility: Ziekenhuis de Tjongerschans
state: Friesland
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis Sneek
state: Friesland
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
state: Gelderland
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
state: Gelderland
city: Ede
country: Netherlands
facility: Gelderse Vallei
state: North Brabant
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
state: North Brabant
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: North Holland
city: Hilversum
country: Netherlands
facility: Tergooi
state: North Holland
city: Amsterdam
country: Netherlands
facility: BovenIJ Ziekenhuis
state: North- Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
state: North- Holland
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: North-Brabant
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
state: South- Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: South-Holland
city: Leiden
country: Netherlands
facility: LUMC
state: South-Holland
city: Terneuzen
country: Netherlands
facility: Zorgsaam Zeeuws -Vlaanderen
state: Zeeland
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Celgene Corporation
name: Jeroen Stevens, Msc
role: STUDY_DIRECTOR
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