A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01668108

Enrollment

770

Registered

2012-08-17

Start date

2012-08-31

Completion date

2018-05-31

Last updated

2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma

Keywords

carcinoma, breast cancer, non-small cell lung cancer, ovarial cancer, ambulant chemotherapy, treatment cycles, Paclitaxel, Paclitaxel onkovis, Quantity of Paclitaxel, Packaging Sizes

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Indication for Paclitaxel according to the SmPC and treating physician

Exclusion criteria

* according to the Paclitaxel SmPC

Design outcomes

Primary

Measure	Time frame	Description
the quantity of Paclitaxel onkovis needed pro treatment cycle	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

Secondary

Measure	Time frame	Description
adverse events during and after treatment in comparison to Docetaxel onkovis	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.

Countries

Germany

Outcome results