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 : Recruiting
First Posted : February 2, 2016
Last Update Posted : February 6, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
|Estimated Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||April 30, 2019|
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).
- 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).
- 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.
- 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.
- 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.
- 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).
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670746
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Ziekenhuis de Tjongerschans||Recruiting|
|Heerenveen, Friesland, Netherlands, 8841 PW|
|Antonius Ziekenhuis Sneek||Recruiting|
|Sneek, Friesland, Netherlands, 8601 ZK|
|Arnhem, Gelderland, Netherlands, 6815 A|
|Breda, Gelderland, Netherlands, 4818 CK|
|Ede, North Brabant, Netherlands, 2545 CH|
|Helmond, North Brabant, Netherlands, 5707 HA|
|Haarlem, North Holland, Netherlands, 2035 RC|
|Hilversum, North Holland, Netherlands, 1213XZ|
|Amsterdam, North- Holland, Netherlands, 1034 CS|
|Academic Medical Centre||Recruiting|
|Amsterdam, North- Holland, Netherlands, 1105 AZ|
|Maxima Medisch Centrum||Recruiting|
|Veldhoven, North-Brabant, Netherlands, 5504 DB|
|Zwolle, Overijssel, Netherlands, 8025 AB|
|The Hague, South- Holland, Netherlands, 2545 CH|
|Albert Schweitzer Ziekenhuis||Recruiting|
|Dordrecht, South-Holland, Netherlands, 3328 AT|
|Leiden, South-Holland, Netherlands, 2333 ZA|
|Zorgsaam Zeeuws -Vlaanderen||Recruiting|
|Terneuzen, Zeeland, Netherlands, 4535 PA|
|Groningen, Netherlands, 9728 NT|
|Utrecht, Netherlands, 3584 CX|
|Study Director:||Jan Koedam, Msc||Celgene Corporation|