NCT01942200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

September 10, 2013

Last Update Submit

August 6, 2018

Conditions

Carcinoma

Keywords

carcinomacolon cancercolorectal cancerambulant chemotherapytreatment cyclesOxaliplatinOxaliplatin onkovisQuantity of OxaliplatinPackaging Sizes

Outcome Measures

Primary Outcomes (1)

  • The Quantity of Oxaliplatin onkovis needed per treatment cycle

    Determine the quantity of Oxaliplatin onkovis needed per treatment cycle

    up to 24 weeks

Secondary Outcomes (1)

  • Adverse events during and after treatment

    up to 24 weeks

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated in practices, clinics, hospitals

You may qualify if:

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

You may not qualify if:

  • According to the Oxaliplatin SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Practice

Elstra, 01920, Germany

Location

Practice

Leipzig, 04277, Germany

Location

Practice

Naunhof, 04683, Germany

Location

MeSH Terms

Conditions

CarcinomaColonic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

DE(3)