A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01840280|
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : May 23, 2018
The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan 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 Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||324 participants|
|Official Title:||Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Carcinoma, Irinotecan onkovis (Irinotecan)
Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma.
- The Quantity of Irinotecan onkovis needed per treatment cycle [ Time Frame: up to 24 weeks ]Determine the quantity of Irinotecan onkovis needed pro treatment cycle
- Adverse events during and after treatment [ Time Frame: up to 24 weeks ]The number and kind of adverse events during and after the intra-venous application of Irinotecan 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): NCT01840280
|Elstra, Germany, 01920|
|Leipzig, Germany, 04179|
|Naunhof, Germany, 04683|
|Neustadt/Sachsen, Germany, 01844|
|Werdau, Germany, 08412|