Glioma Clinical Trials

Find Glioma Clinical Trials Near You

Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune)

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Newly diagnosed glioblastoma/gliosarcoma, IDH wild type

• Methylated MGMT promoter

• World Health Organization performance status 0-2

• Age 18-70

Locations
Other Locations
Austria
University Hospital Graz
NOT_YET_RECRUITING
Graz
Medizinische Universität Innsbruck
NOT_YET_RECRUITING
Innsbruck
Kepler University Hospital
RECRUITING
Linz
University Hospital St. Pölten
ENROLLING_BY_INVITATION
Sankt Pölten
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Norway
Haukeland University Hospital
RECRUITING
Bergen
Sorlandet Sykehus
RECRUITING
Kristiansand
Oslo University Hospital
RECRUITING
Oslo
Stavanger University Hospital
NOT_YET_RECRUITING
Stavanger
St Olavs Hospital
NOT_YET_RECRUITING
Trondheim
Sweden
Gävle Hospital
RECRUITING
Gävle
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Ryhov County Hospital
RECRUITING
Jönköping
Kalmar Country Hospital
RECRUITING
Kalmar
Skåne University Hospital
NOT_YET_RECRUITING
Lund
Örebro University Hospital
RECRUITING
Örebro
Karolinska Institutet
ENROLLING_BY_INVITATION
Stockholm
Sundsvall Hospital
ENROLLING_BY_INVITATION
Sundsvall
Norrlands Universitetssjukhus, Umea, Sweden
RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Asgeir S Jakola, MD, PhD
asgeir.jakola@vgregion.se
+46313429741
Backup
Annika Malmström, MD. PhD
annika.malmstrom@regionostergotland.se
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2033-12-15
Participants
Target number of participants: 200
Treatments
Experimental: treatment arm
arm with temozolomide (TMZ) plus lomustine (LOM) treatment.~6 cycles of LOM/TMZ Start day 1 of RT. Cycle length of 42 days. Duration 9 months.
Active_comparator: standard arm
arm with standard of care treatment with temozolomide only.~Oral TMZ 75 mg/m2 daily during RT and with start day 1 of RT. This is followed by 6 cycles of TMZ with start 4 weeks after the end of RT. Cycle length 28 days. Duration 8,5 months.
Sponsors
Collaborators: Karolinska Institutet, University Hospital of Sankt Pölten, Kalmar County Hospital, Kepler University Hospital, Uppsala University Hospital, Helse Stavanger HF, Gävle Hospital, Sorlandet Hospital HF, Skane University Hospital, Aarhus University Hospital, Norrlands Universitetssjukhus, Umea, Sweden, St. Olavs Hospital, medizinische universität innsbruck, Austria, Haukeland University Hospital, Ryhov County Hospital, Region Örebro County, Oslo University Hospital, Sundsvalls Hospital, University Hospital Graz, Sahlgrenska University Hospital
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov