Actively Recruiting
Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
Led by Vastra Gotaland Region · Updated on 2026-04-13
200
Participants Needed
20
Research Sites
462 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
S
Skane University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile. Hypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ. Treatment Plans: The study will randomly assign participants to two groups: * Control Group: Standard treatment with TMZ during and after radiation therapy. * Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy. Outcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes.
CONDITIONS
Official Title
Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed glioblastoma or gliosarcoma, IDH wild type
- Methylated MGMT promoter
- World Health Organization performance status 0 to 2
- Age between 18 and 70 years
You will not qualify if you...
- Previous malignancy within 3 years or malignancy treated non-curatively
- Previous chemotherapy or radiotherapy involving the head
- Off-protocol tumor-specific treatment
- Serious comorbidity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University Hospital Graz
Graz, Austria
Not Yet Recruiting
2
Medizinische Universität Innsbruck
Innsbruck, Austria
Not Yet Recruiting
3
Kepler University Hospital
Linz, Austria
Actively Recruiting
4
University Hospital St. Pölten
Sankt Pölten, Austria
Enrolling by Invitation
5
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
6
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
7
Sorlandet Sykehus
Kristiansand, Norway
Actively Recruiting
8
Oslo University Hospital
Oslo, Norway
Actively Recruiting
9
Stavanger University Hospital
Stavanger, Norway
Not Yet Recruiting
10
St Olavs Hospital
Trondheim, Norway
Not Yet Recruiting
11
Gävle Hospital
Gävle, Sweden
Actively Recruiting
12
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
13
Ryhov County Hospital
Jönköping, Sweden
Actively Recruiting
14
Kalmar Country Hospital
Kalmar, Sweden
Actively Recruiting
15
Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
16
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
17
Karolinska Institutet
Stockholm, Sweden
Enrolling by Invitation
18
Sundsvall Hospital
Sundsvall, Sweden
Enrolling by Invitation
19
Norrlands Universitetssjukhus, Umea, Sweden
Umeå, Sweden
Actively Recruiting
20
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
A
Asgeir S Jakola, MD, PhD
CONTACT
A
Annika Malmström, MD. PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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