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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01942200

Enrollment

383

Registered

2013-09-13

Start date

2013-09-30

Completion date

2018-07-25

Last updated

2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma

Keywords

carcinoma, colon cancer, colorectal cancer, ambulant chemotherapy, treatment cycles, Oxaliplatin, Oxaliplatin onkovis, Quantity of Oxaliplatin, Packaging Sizes

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* According to the Oxaliplatin SmPC

Design outcomes

Primary

Measure	Time frame	Description
The Quantity of Oxaliplatin onkovis needed per treatment cycle	up to 24 weeks	Determine the quantity of Oxaliplatin onkovis needed per treatment cycle

Secondary

Measure	Time frame	Description
Adverse events during and after treatment	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.

Countries

Germany

Outcome results