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

NCT02691052 | Completed

• 1 other identifier: QoliXane
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancer; metastatic

Outcome Measures

Primary Outcomes (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

  3 months

Secondary Outcomes (14)

• Global Health Status/Quality of Life Score at 6 months

  6 months

• Limited Baseline Condition

  3 and 6 months

• Therapy effects on Global Health Status/Quality of Life Score

  3 months

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

  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

  6 months

Study Arms (1)

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

Interventions

Quality of Life questionnaire OTHER

EORTC QLQ-C30 questionnaire

Also known as: EORTC QLQ-C30

Pts receiving nab-paclitaxel/gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Trium Analysis Online GmbH: collaborator
• mca Berlin: collaborator

Study Sites (1)

Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research

Frankfurt, 60488, Germany

Location

Related Publications (1)

• 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.

  PMID: 33038277 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor containing tissues are collected for a translational program focusing on defining prognostic and predictive factors.

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salah-Eddin Al-Batran, Prof. Dr.

  Institute of Clinical Cancer Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 25, 2016
• Study Start: December 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)