A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer
The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy.
onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.
Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Open, Multicenter Observational Study of Paclitaxel Utilized in Mono- or Combination Therapy for the Treatment of Breast Cancer, Non-small Cell Lung Cancer and Ovarial Cancer.|
- the quantity of Paclitaxel onkovis needed pro treatment cycle [ Time Frame: the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles). ] [ Designated as safety issue: No ]Determine the quantity of Paclitaxel onkovis needed pro treatment cycle
- adverse events during and after treatment in comparison to Docetaxel onkovis [ Time Frame: up to 24 weeks (8 cycles) ] [ Designated as safety issue: Yes ]The number and kind of adverse events during and after the intra-venous application of Paclitaxel will be assessed, documented and compared to those of Docetaxel.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
carcinoma, Paclitaxel onkovis (Paclitaxel)
treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668108
|Contact: K.-U. Seiler, PD Dr. med.||+49(0)firstname.lastname@example.org|
|Brandenburg, Germany, 14770|
|Chemnitz, Germany, 09117|
|Dresden, Germany, 01307|
|Mühlhausen, Germany, 99974|
|Plauen, Germany, 08525|