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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 : Recruiting
First Posted : February 25, 2016
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Observational
Estimated 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
Primary Completion Date : September 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Gerrit zur Hausen, Dr. +49697601 ext 4562 zurhausen.gerrit@khnw.de

Locations
Germany
Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research Recruiting
Frankfurt, Germany, 60488
Contact: Gerrit zur Hausen, Dr.    +49697601 ext 4562    zurhausen.gerrit@khnw.de   
Principal Investigator: Salah-Eddin Al-Batran, Prof. Dr.         
Sponsors and Collaborators
IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
Trium Analysis Online GmbH
mca Berlin
Investigators
Study Director: Salah-Eddin Al-Batran, Prof. Dr. Institute of Clinical Cancer Research
More Information

Responsible Party: IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT02691052     History of Changes
Other Study ID Numbers: QoliXane
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest:
pancreatic cancer
metastatic

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs