Clinical trial NCT01614002: A Non Interventional Study With Doce Onkovis (Docetaxel) Utilized for the Treatment of Cancer
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Onkovis GmbH
Sponsor class: INDUSTRY
Collaborators: name: AKP Freiburg GmbH
First posted: 2012-06-07
Enrollment: 371
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in practices, clinics, hospitals

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.


Eligibility criteria: Inclusion Criteria:

* Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

* according to the Docetaxel SmPC

Primary outcomes:
measure: the quantity of Doce onkovis needed pro treatment cycle
timeFrame: 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).
Secondary outcomes:
measure: adverse events during and after treatment
timeFrame: up to 24 weeks (8 cycles)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Practice
city: Brandenburg
country: Germany
facility: Practice
city: Chemnitz
country: Germany
facility: Practice
city: Cottbus
country: Germany
facility: Practice
city: Dresden
country: Germany
facility: Practice
city: Elstra
country: Germany
facility: Practice
city: Freital
country: Germany
facility: Practice
city: Fürstenwalde
country: Germany
facility: Practice
city: Halle/Saale
country: Germany
facility: Practice
city: Kronach
country: Germany
facility: Practice
city: Köthen
country: Germany
facility: Practice
city: Leipzig
country: Germany
facility: Hospital
city: Leipzig
country: Germany
facility: Practice
city: Magdeburg
country: Germany
facility: Practice
city: Meiningen
country: Germany
facility: Practice
city: Mühlhausen
country: Germany
facility: Practice
city: Parchim
country: Germany
facility: Practice
city: Plauen
country: Germany
facility: Practice
city: Scheibenberg
country: Germany
facility: Practice
city: Torgau
country: Germany
facility: Clinic
city: Werdau
country: Germany
facility: Practice
city: Zittau
country: Germany
facility: Practice
city: Zwickau
country: Germany
facility: Practice
Study officials:
References: