A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01668108|
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : February 28, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|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.|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
carcinoma, Paclitaxel onkovis (Paclitaxel)
treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- 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). ]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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|