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

Open, Multicenter Observational Study of Docetaxel Utilized in Mono- or Combination Therapy for Treatment of Breast Cancer, NSCLC, Prostate Carcinoma, Adenocarcinoma of Stomach and Advanced Squamous Cell Carcinoma of Head/Neck Region.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01614002

Enrollment

371

Registered

2012-06-07

Start date

2012-05-31

Completion date

2015-03-31

Last updated

2015-06-04

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, prostata cancer, adenocarcinoma of the stomach, squamous cell carcinoma of the head and neck region, ambulant chemotherapy, treatment cycles, Docetaxel, Doce onkovis, Quantity of Docetaxel, Packaging Sizes

Brief summary

The main purpose of this observational study with Docetaxel is to determine the number of treatment cycles and the quantity of Doce 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 evaluation of the safety and tolerability of Doce onkovis. To this purpose data regarding co medications and adverse events are also collected.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Indication for Docetaxel according to the SmPC and treating physician

Exclusion criteria

* according to the Docetaxel SmPC

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
adverse events during and after treatment	up to 24 weeks (8 cycles)	The number and kind of adverse events during and after the intra-venous application of Docetaxel will be assessed and documented.

Countries

Germany

Outcome results