Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    qolixane
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 12, 2016
First Posted Date February 25, 2016
Last Update Posted Date April 21, 2020
Study Start Date December 2014
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 19, 2016)
  • 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
  • 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
  • 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
  • Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30 [ Time Frame: 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 ]
  • Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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 ]
  • Tumor response (RECIST) [ Time Frame: 6 months ]
  • Progression free survival as assessed by tumor response [ Time Frame: 6 months ]
  • Overall survival as assessed by survival data one year after patient enrollment [ Time Frame: 1 year ]
  • Efficacy in high ECOG and high bilirubin patients [ Time Frame: 6 months ]
  • Adverse events [ Time Frame: 6 months ]
  • Adverse events in special subgroups like high ECOG or high bilirubin patients [ Time Frame: 6 months ]
  • Correlations of tumor response and survival with genetic alterations [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program
Official Title Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Tumor containing tissues are collected for a translational program focusing on defining prognostic and predictive factors.
Sampling Method Non-Probability Sample
Study Population Patients with metastatic pancreatic cancer subject to firstline therapy with nab-paclitaxel and gemcitabine
Condition Metastatic Pancreatic Cancer
Intervention Other: Quality of Life questionnaire
EORTC QLQ-C30 questionnaire
Other Name: EORTC QLQ-C30
Study Groups/Cohorts 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.
Intervention: Other: Quality of Life questionnaire
Publications * Al-Batran SE, Hofheinz RD, Reichart A, Pauligk C, Schönherr C, Schlag R, Siegler G, Dörfel S, Koenigsmann M, Zahn MO, Schubert J, Aldaoud A, Höffkes 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, Wörns MA, Harich HD, von Weikersthal LF, Däßler KU, Behringer DM, Messmann H, Kretzschmar A, Gallmeier E, Forstbauer H, Kunzmann V, Papke J, Büchner-Steudel P, Vehling-Kaiser U, Springfeld C, Vogel A, Ettrich TJ, Schaaf M, Hausen GZ, Götze 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 19, 2016)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02691052
Other Study ID Numbers QoliXane
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Responsible Party Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators
  • Trium Analysis Online GmbH
  • mca Berlin
Investigators
Study Director: Salah-Eddin Al-Batran, Prof. Dr. Institute of Clinical Cancer Research
PRS Account Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Verification Date April 2020