Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06419946 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary completion date: Dec 15, 2028 to Dec 15, 2031
    • Study sites: 0 to 20
    • Study completion date: Dec 15, 2031 to Dec 15, 2033
    • Start date changed from estimate of Dec 1, 2024 to Feb 1, 2025
    • Collaborators: 16 to 20
  2. Notable Start date: May 15, 2024 to Dec 1, 2024
    • Secondary endpoints: details revised at 1 of 11 entries
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,251 trials monitored
See 88 trials at risk
710 trials monitored
See 52 trials at risk
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.
Trial Details
NCT Number NCT06419946
Lead Sponsor Vastra Gotaland Region
Collaborators: Skane University Hospital, Gävle Hospital, Karolinska Institutet, Sahlgrenska University Hospital, Ryhov County Hospital, Kalmar County Hospital, Oslo University Hospital, St. Olavs Hospital, Haukeland University Hospital, Sorlandet Hospital HF, Helse Stavanger HF, Aarhus University Hospital, Region Örebro County, University Hospital, Umeå, Uppsala University Hospital, Universitäts-Frauenklinik Graz, University Hospital of Sankt Pölten, Sundsvalls Hospital, Kepler University Hospital, medizinische universität innsbruck, Austria
Conditions
(from sponsor)
Glioblastoma, IDH-wildtype, MGMT-Methylated Glioblastoma
Related terms Glioblastoma
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov