A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer

August 6, 2018 updated by: Onkovis GmbH

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Elstra, Germany, 01920
        • Practice
      • Leipzig, Germany, 04277
        • Practice
      • Naunhof, Germany, 04683
        • Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated in practices, clinics, hospitals

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • According to the Oxaliplatin SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onkovis GmbH

Collaborators

AKP Freiburg GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

July 25, 2018

Study Completion (ACTUAL)

July 25, 2018

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (ESTIMATE)

September 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONKOOXA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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