CarcinomaNCT01840280
A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer
An observational study of Carcinoma, run by Onkovis GmbH at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma
- How many people
- 324 participants
- Where
- 5 sitesGermany
- Study dates
- Apr 2013to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in practices, clinics, hospitals
Who may be able to join
- Indication for Irinotecan according to the SmPC and treating physician
Who cannot join
- according to the Irinotecan SmPC
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Practice
Elstra, 01920
Practice
Leipzig, 04179
Practice
Naunhof, 04683
Practice
Neustadt/Sachsen, 01844
Practice
Werdau, 08412
About this study
Official title: Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
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.
- Conditions
- Carcinoma
- Keywords
- carcinoma, colorectal cancer, ambulant chemotherapy, treatment cycles, Irinotecan, Irinotecan onkovis, Quantity of Irinotecan, Packaging Sizes
- Medical subject headings
- Carcinoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carcinoma, Irinotecan onkovis (Irinotecan) | Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quantity of Irinotecan onkovis needed per treatment cycle
Determine the quantity of Irinotecan onkovis needed pro treatment cycle
Measured: up to 24 weeks
Secondary outcomes (1)
Adverse events during and after treatment
The number and kind of adverse events during and after the intra-venous application of Irinotecan will be assessed and documented.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onkovis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AKP Freiburg GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840280
- Sponsor's protocol ID
- ONKOIRI01
- Status last verified
- May 2018
- First submitted
- 22 Apr 2013
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
- ClinicalTrials.gov ID
- NCT01840280
- Acronym / sponsor ID
- ONKOIRI01
- Conditions
- Carcinoma
- Keywords
- carcinoma, colorectal cancer, ambulant chemotherapy, treatment cycles, Irinotecan, Irinotecan onkovis, Quantity of Irinotecan, Packaging Sizes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Onkovis GmbHIndustry (pharma, biotech, devices)
- Collaborators
- AKP Freiburg GmbH
- Study start
- Apr 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carcinoma, Irinotecan onkovis (Irinotecan) | – | –Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in practices, clinics, hospitals
Key inclusion criteria (1 listed)
- Indication for Irinotecan according to the SmPC and treating physician
Key exclusion criteria (1 listed)
- according to the Irinotecan SmPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Quantity of Irinotecan onkovis needed per treatment cycle
Time frame: up to 24 weeks
Determine the quantity of Irinotecan onkovis needed pro treatment cycle
1 secondary outcome
Adverse events during and after treatment
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, run by Onkovis GmbH at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quantity of Irinotecan onkovis needed per treatment cycle (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.