Clinical trial · Observational
A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer
Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Carcinoma, Irinotecan onkovis (Irinotecan)
- description
- Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma.
Primary outcomes (1)
- measure
- The Quantity of Irinotecan onkovis needed per treatment cycle
- timeFrame
- up to 24 weeks
- description
- Determine the quantity of Irinotecan onkovis needed pro treatment cycle
Secondary outcomes (1)
- measure
- Adverse events during and after treatment
- timeFrame
- up to 24 weeks
- description
- The number and kind of adverse events during and after the intra-venous application of Irinotecan will be assessed and documented.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Indication for Irinotecan according to the SmPC and treating physician Exclusion Criteria: * according to the Irinotecan SmPC
References
Publications (0)
Data not yet available