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NCT Number: NCT02691052

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

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.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research

Frankfurt, 60488, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of Life Questionnaire

Other

EORTC QLQ-C30 questionnaire

Other names: EORTC QLQ-C30

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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

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

    Time frame: 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

    Time frame: 6 months

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

    Time frame: 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

    Time frame: 6 months

  8. Tumor response (RECIST)

    Time frame: 6 months

  9. Progression free survival as assessed by tumor response

    Time frame: 6 months

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

    Time frame: 1 year

  11. Efficacy in high ECOG and high bilirubin patients

    Time frame: 6 months

  12. Adverse events

    Time frame: 6 months

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

    Time frame: 6 months

  14. Correlations of tumor response and survival with genetic alterations

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Other

Collaborators

  • Trium Analysis Online GmbH
  • mca Berlin

Registry information

Official study title

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

Acronym: QoliXane

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2016
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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