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
-
-
-
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.
|
EORTC QLQ-C30 questionnaire
Other Names:
|
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.
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.
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.