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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status: Completed

Conditions: Metastatic Pancreatic Cancer

Treatments: Other: Quality of Life questionnaire

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02691052

QoliXane

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Pts receiving nab-paclitaxel/gemcitabine

Description:

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.

Treatment:

Other: Quality of Life questionnaire