2022-502345-10-00CompletedPhase 4
The effect of oral folinic acid to prevent pemetrexed induced adverse events.
The effect of oral folinic acid rescue therapy on pemetrexed induced neutropenia and other toxicity: A randomized open-label trial.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Mar 2023
Brief summary (registry, in English)
The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 20 Oct 2022
- Start date
- 5 Feb 2023
- Lead sponsor
- Amphia Hospital
- Diseases
- Lung cancer, Mesothelioma
- EU CT number
- 2022-502345-10-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for treatment with folinic acid in line with the SmPC. a. Hypersensitivity to the active substance or to any of the excipients. b. Anaemia caused by vitamin B12 deficiency.
- The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
Who the study is looking for
- ≥18 years old
- Eligible for treatment with pemetrexed-based chemotherapy based on indication.
- ECOG performance score of 0-2.
- Subject is able and willing to sign the Informed Consent Form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amphia Hospital | Breda | Netherlands | Completed |
| Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.