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Metastatic Pancreatic CancerQoliXaneNCT02691052

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

An observational study of Metastatic Pancreatic Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Quality of Life questionnaire
How many people
600 participants
Where
1 siteGermany
Study dates
Dec 2014to Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research

    Frankfurt, 60488

Other trials in Germany

About this study

Official title: 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.

Being tested
Quality of Life questionnaire
Keywords
pancreatic cancer, metastatic
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality of Life questionnaireOther

    Also called EORTC QLQ-C30

    EORTC QLQ-C30 questionnaire

Study groups in NCT02691052
Study groupRoleWhat they receive
Pts receiving nab-paclitaxel/gemcitabinePatients 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.
Receives: Other: Quality of Life questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Health Status/Quality of Life Score at 3 months

    Rate of patients without deterioration of their global health status/quality of life score according to EORTC QLQ-C30 after 3 months

    Measured: 3 months

Secondary outcomes (14)

  1. Global Health Status/Quality of Life Score at 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

    Measured: 6 months

  2. Limited Baseline Condition

    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

    Measured: 3 and 6 months

  3. Therapy effects on Global Health Status/Quality of Life Score

    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

    Measured: 3 months

  4. Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30

    Measured: 6 months

  5. Median time until definitive deterioration of Global Health Status/Quality of Life Score and other functional and symptom scales of EORTC QLQ-C30

    Measured: 6 months

  6. Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. Tumor response (RECIST)

    Measured: 6 months

  9. Progression free survival as assessed by tumor response

    Measured: 6 months

  10. Overall survival as assessed by survival data one year after patient enrollment

    Measured: 1 year

  11. Efficacy in high ECOG and high bilirubin patients

    Measured: 6 months

  12. Adverse events

    Measured: 6 months

  13. Adverse events in special subgroups like high ECOG or high bilirubin patients

    Measured: 6 months

  14. Correlations of tumor response and survival with genetic alterations

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2016 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2019
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691052
Sponsor's protocol ID
QoliXane
Acronym
QoliXane
Status last verified
Apr 2020
First submitted
12 Feb 2016
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No IPD will be shared.

Publications

  • Al-Batran SE, Hofheinz RD, Reichart A, Pauligk C, Schonherr C, Schlag R, Siegler G, Dorfel S, Koenigsmann M, Zahn MO, Schubert J, Aldaoud A, Hoffkes HG, Schulz H, Hahn L, Uhlig J, Blau W, Stauch M, Weniger J, Wolf M, Jacobasch L, Bildat S, Wehmeyer J, Homann N, Trojan J, Waidmann O, Fietz T, Feustel HP, Groschek M, Wierecky J, Waibel K, Mahlmann S, Schwindel U, Peters U, Schuch G, Pink D, Eschenburg H, Worns MA, Harich HD, von Weikersthal LF, Dassler KU, Behringer DM, Messmann H, Kretzschmar A, Gallmeier E, Forstbauer H, Kunzmann V, Papke J, Buchner-Steudel P, Vehling-Kaiser U, Springfeld C, Vogel A, Ettrich TJ, Schaaf M, Hausen GZ, Gotze TO; Arbeitsgemeinschaft Internistische Onkologie (AIO). Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry. Int J Cancer. 2021 Mar 15;148(6):1478-1488. doi: 10.1002/ijc.33336. Epub 2020 Oct 23.

    PubMed 33038277

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Pancreatic Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Health Status/Quality of Life Score at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02691052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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