A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
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|ClinicalTrials.gov Identifier: NCT01942200|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : August 7, 2018
The main purpose of this observational study with Oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.
Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.
Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this end, data regarding co-medication and adverse events are also collected.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||383 participants|
|Official Title:||Open, Multicenter Observational Study of Oxaliplatin Utilized in Combination Therapy for Adjuvant Treatment of Colon Carcinoma of Stage III After Complete Removal of the Primary Tumor and for Treatment of Metastasizing Colorectal Carcinoma.|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 25, 2018|
|Actual Study Completion Date :||July 25, 2018|
Carcinoma, Oxaliplatin onkovis (Oxaliplatin)
Treatment in combination therapy for adjuvant treatment of colon carcinoma of stage III (Dukes C) after complete removal of the primary tumor, as well as for treatment of metastasizing colorectal carcinoma.
- The Quantity of Oxaliplatin onkovis needed per treatment cycle [ Time Frame: up to 24 weeks ]Determine the quantity of Oxaliplatin onkovis needed per treatment cycle
- Adverse events during and after treatment [ Time Frame: up to 24 weeks ]The number and type of adverse events during and after the intra-venous application of Oxaliplatin will be assessed and documented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942200
|Elstra, Germany, 01920|
|Leipzig, Germany, 04277|
|Naunhof, Germany, 04683|