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A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) 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. Identifier: NCT01942200
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : August 7, 2018
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 383 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated in practices, clinics, hospitals

Inclusion Criteria:

  • Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician

Exclusion Criteria:

  • According to the Oxaliplatin SmPC

Information from the National Library of Medicine

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 identifier (NCT number): NCT01942200

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Elstra, Germany, 01920
Leipzig, Germany, 04277
Naunhof, Germany, 04683
Sponsors and Collaborators
Onkovis GmbH
AKP Freiburg GmbH

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Responsible Party: Onkovis GmbH Identifier: NCT01942200     History of Changes
Other Study ID Numbers: ONKOOXA01
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Keywords provided by Onkovis GmbH:
colon cancer
colorectal cancer
ambulant chemotherapy
treatment cycles
Oxaliplatin onkovis
Quantity of Oxaliplatin
Packaging Sizes
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents