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

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ClinicalTrials.gov Identifier: NCT02691052
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Trium Analysis Online GmbH
mca Berlin
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Brief 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. 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.


Condition or disease Intervention/treatment
Metastatic Pancreatic Cancer Other: Quality of Life questionnaire

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer
Study Start Date : December 2014
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019


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 Name: EORTC QLQ-C30




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Tumor containing tissues are collected for a translational program focusing on defining prognostic and predictive factors.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic pancreatic cancer subject to firstline therapy with nab-paclitaxel and gemcitabine
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691052


Locations
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Germany
Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research
Frankfurt, Germany, 60488
Sponsors and Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Trium Analysis Online GmbH
mca Berlin
Investigators
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Study Director: Salah-Eddin Al-Batran, Prof. Dr. Institute of Clinical Cancer Research
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Responsible Party: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT02691052    
Other Study ID Numbers: QoliXane
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Keywords provided by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest:
pancreatic cancer
metastatic
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases