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.
1 other identifier
observational
371
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 4, 2015
June 1, 2015
2.8 years
June 1, 2012
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the quantity of Doce onkovis needed pro treatment cycle
Determine 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).
Secondary Outcomes (1)
adverse events during and after treatment
up to 24 weeks (8 cycles)
Study Arms (1)
carcinoma, Doce onkovis (Docetaxel)
treatment in mono- or combination therapy with Docetaxel of breast cancer, non-small cell lung cancer, prostata carcinoma, adenocarcinoma of the stomach and advanced squamous cell carcinoma of the head/neck region.
Eligibility Criteria
Patients treated in practices, clinics, hospitals
You may qualify if:
- Indication for Docetaxel according to the SmPC and treating physician
You may not qualify if:
- according to the Docetaxel SmPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Onkovis GmbHlead
- AKP Freiburg GmbHcollaborator
Study Sites (23)
Practice
Berlin, 13156, Germany
Practice
Brandenburg, 14770, Germany
Practice
Chemnitz, 09117, Germany
Practice
Cottbus, 03055, Germany
Practice
Dresden, 01307, Germany
Practice
Elstra, 01920, Germany
Practice
Freital, 01705, Germany
Practice
Fürstenwalde, 15517, Germany
Practice
Halle, 06132, Germany
Practice
Köthen, 06366, Germany
Practice
Kronach, 96317, Germany
Hospital
Leipzig, 04277, Germany
Practice
Leipzig, 04277, Germany
Practice
Magdeburg, 39104, Germany
Practice
Meiningen, 98617, Germany
Practice
Mühlhausen, 99974, Germany
Practice
Parchim, 19370, Germany
Practice
Plauen, 08525, Germany
Practice
Scheibenberg, 09481, Germany
Clinic
Torgau, 04860, Germany
Practice
Werdau, 08412, Germany
Practice
Zittau, 02763, Germany
Practice
Zwickau, 08060, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2012
First Posted
June 7, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 4, 2015
Record last verified: 2015-06