Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program (QoliXane)

April 20, 2020 updated by: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer

Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL) under this combination therapy. In the framework of a German multicenter prospective, observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under treatment will be analyzed and data will be compared to existing data of the gemcitabine mono therapy.

QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over a 6-month period. Additionally patients are requested to answer a supplementary questionnaire addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

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

  • Germany
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research

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

Patients with metastatic pancreatic cancer subject to firstline therapy with nab-paclitaxel and gemcitabine

Description

Inclusion Criteria:

  • metastatic pancreatic carcinoma
  • no previous therapy in the metastatic stage
  • planned firstline therapy with nab-paclitaxel and gemcitabine

Exclusion Criteria:

  • previous therapy in the metastatic stage
  • patient unable to understand the study and to give informed consent
  • patient unable to answer quality of life questionnaires

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pts receiving nab-paclitaxel/gemcitabine
Patients with metastatic pancreatic cancer undergoing a firstline therapy with nab-paclitaxel and gemcitabine will be asked to fill in an EORTC QLQ-C30 questionnaire and an additional questionnaire on worries about quality of life impairments every 4 weeks. No further intervention.
Other: Quality of Life questionnaire
EORTC QLQ-C30 questionnaire
Other Names:
  • EORTC QLQ-C30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Health Status/Quality of Life Score at 3 months
Time Frame: 3 months
Rate of patients without deterioration of their global health status/quality of life score according to EORTC QLQ-C30 after 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 months
6 months
Global Health Status/Quality of Life Score at 6 months
Time Frame: 6 months
Rate of patients with an improvement of their global health status/quality of life score according to EORTC QLQ-C30 after 6 months
6 months
Limited Baseline Condition
Time Frame: 3 and 6 months
Rate of patients with a limited baseline general condition (ECOG 2 or 3) and stable or improved Global Health Status/Quality of Life Score after 3 and 6 months
3 and 6 months
Therapy effects on Global Health Status/Quality of Life Score
Time Frame: 3 months
Effect of therapy on Global Health Status/Quality of Life Score and other symptoms and scales assessed by EORTC QLQ-C30: rate of patients with improved, stable or deteriorated score
3 months
Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30
Time Frame: 6 months
6 months
Median time until definitive deterioration of Global Health Status/Quality of Life Score and other functional and symptom scales of EORTC QLQ-C30
Time Frame: 6 months
6 months
Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months
6 months
Comparison of Global Health/Quality of Life scores as assessed by EORTC QLQ-C30 to historical Global Health/Quality of Life score data of gemcitabine mono-therapy
Time Frame: 6 months
6 months
Tumor response (RECIST)
Time Frame: 6 months
6 months
Progression free survival as assessed by tumor response
Time Frame: 6 months
6 months
Overall survival as assessed by survival data one year after patient enrollment
Time Frame: 1 year
1 year
Efficacy in high ECOG and high bilirubin patients
Time Frame: 6 months
6 months
Adverse events in special subgroups like high ECOG or high bilirubin patients
Time Frame: 6 months
6 months
Correlations of tumor response and survival with genetic alterations
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborators

Trium Analysis Online GmbH
mca Berlin

Investigators

  • Study Director: Salah-Eddin Al-Batran, Prof. Dr., Institute of clinical cancer research

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

December 1, 2014

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoliXane

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared.

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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