2024-519437-27-02RecruitingPhase 3
A randomized phase III trial with lomustine versus lomustine and bevacizumab for patients with recurrent glioblastoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary endpoint is overall survival
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 10 Dec 2024
- Start date
- 3 Feb 2025
- Lead sponsor
- Rigshospitalet
- Diseases
- Glioblastoma
- EU CT number
- 2024-519437-27-02
- EudraCT number
- 2020-003545-11
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 168
- 4 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.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose glioblastoma has come back after first treatment with radiotherapy and temozolomide chemotherapy (the STUPP regimen). It compares lomustine alone with lomustine plus bevacizumab.
- Age
- Older than 18 years
- Sex
- All sexes
- Disease stage
- Glioblastoma confirmed under the microscope, coming back for the first time after radiotherapy with temozolomide chemotherapy (STUPP regimen). In case of early progression, at least 3 months after radiotherapy ended and at least 4 weeks after adjuvant chemotherapy.
- Earlier treatment
- Must have had the STUPP regimen. No more than one line of chemotherapy. Must not have had any treatment for the recurrence, including temozolomide again, or any drug aimed at the VEGF pathway.
Main reasons for not taking part
- Any earlier treatment for the recurrent glioblastoma, including temozolomide again
- Earlier use of a drug aimed at the VEGF pathway
- Medicines that could affect the results, such as immunosuppressive drugs (corticosteroids are allowed)
- Another cancer now or within the past 5 years, except treated basal or squamous cell skin cancer or cervical carcinoma in situ
- Medical, social or physical conditions that could get in the way of information or follow-up
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Previous therapy of recurrent GBM including temozolomide reinduction. • Previous use of biological drug targeting the VEGF-signaling pathway • Concurrent use of medication that can affect the interpretation of the results from the study, e.g. use of immunosuppressive drugs, except corticosteroids • Conditions (medical, social or physical) that may compromise proper information and/or follow-up • Other concurrent or previous cancer within 5 years, except adequately treated basal or squamous cell skin cancer, or cervical carcinoma in situ
Who the study is looking for
- Signed informed consent • Histological verified glioblastoma • Recurrent GBM, previously treated according the STUPP regimen • No more than one line of chemotherapy (concurrent and adjuvant temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). • PS 0-1 • Age > 18 • Expected survival > 3 months • First progression after RT concurrent/adjuvant chemotherapy (STUPPS regimen). In case of early progression, then at least 3 months after termination of radiotherapy and at least 4 weeks after adjuvant chemotherapy. • No more than one line of chemotherapy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital | Aarhus N | Denmark | Recruiting |
| Copenhagen University Hospital | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital | Odense C | Denmark | Recruiting |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.