Carcinoma Clinical Trial
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.
| NCT number | NCT01942200 |
| Other study ID # | ONKOOXA01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2013 |
| Est. completion date | July 25, 2018 |
| Verified date | August 2018 |
| Source | Onkovis GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 383 |
| Est. completion date | July 25, 2018 |
| Est. primary completion date | July 25, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician Exclusion Criteria: - According to the Oxaliplatin SmPC |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Practice | Elstra | |
| Germany | Practice | Leipzig | |
| Germany | Practice | Naunhof |
| Lead Sponsor | Collaborator |
|---|---|
| Onkovis GmbH | AKP Freiburg GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Quantity of Oxaliplatin onkovis needed per treatment cycle | Determine the quantity of Oxaliplatin onkovis needed per treatment cycle | up to 24 weeks | |
| Secondary | Adverse events during and after treatment | 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 |
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