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

Study Overview
=================
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.

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)

Conditions
-----------------
Pancreatic Neoplasms

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nab-paclitaxel in combination with gemcitabine (AG)<br>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 | 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) | 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 ) | 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) | 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 | 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 | Descriptive analysis of incidence and severity of neuropathy according to physicians assessment | up to approximately 3 years | 
| Evaluate reversibility of neuropathy to Gr ≤1 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer, Observational, Nab-Paclitaxel, Abraxane, ABI-007, Gemcitabine, Non-interventional, Netherlands, Quality of Life