NCT01840280

Brief Summary

The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan 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 Irinotecan 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
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 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

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

April 22, 2013

Last Update Submit

May 22, 2018

Conditions

Carcinoma

Keywords

carcinomacolorectal cancerambulant chemotherapytreatment cyclesIrinotecanIrinotecan onkovisQuantity of IrinotecanPackaging Sizes

Outcome Measures

Primary Outcomes (1)

  • The Quantity of Irinotecan onkovis needed per treatment cycle

    Determine the quantity of Irinotecan onkovis needed pro treatment cycle

    up to 24 weeks

Secondary Outcomes (1)

  • Adverse events during and after treatment

    up to 24 weeks

Study Arms (1)

Carcinoma, Irinotecan onkovis (Irinotecan)

Treatment in mono- or combination therapy with Irinotecan of advanced 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 Irinotecan according to the SmPC and treating physician

You may not qualify if:

  • according to the Irinotecan SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Practice

Elstra, 01920, Germany

Location

Practice

Leipzig, 04179, Germany

Location

Practice

Naunhof, 04683, Germany

Location

Practice

Neustadt/Sachsen, 01844, Germany

Location

Practice

Werdau, 08412, Germany

Location

MeSH Terms

Conditions

CarcinomaColorectal 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

April 22, 2013

First Posted

April 25, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

DE(5)