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Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study

NCT05904119 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2026-02-17

No results posted yet for this study

Summary

Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all patients suffer from tumour relapse. Currently, no standard of care exists to treat these tumour relapses. Treatment options include repeated surgery (if feasible), systemic therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best supportive care. Currently, the superiority of combined chemoradiation versus chemotherapy alone remains unproven. Given that lomustine is the standard chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the unclear efficacy of reirradiation, we want to explore whether combining lomustine and reirradiation may be a better treatment than lomustine alone. The results of the prospective randomized trial proposed here should demonstrate a significant improvement in overall survival when lomustine is combined with reirradiation in patients with recurrent glioblastoma compared to lomustine alone without adversely affecting quality of survival. The trial will be stopped based on overall survival in a preplanned futility and efficacy interim analysis.

Conditions

  • First Progression of Glioblastoma

Interventions

DRUG

Lomustine

Oral administration of Lomustine

RADIATION

Reirradiation

Given at least 6 months after the end of prior radiotherapy

Sponsors & Collaborators

  • Swiss Cancer Institute

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Matthias Preusser, Prof. · EORTC Study Coordinator

  • Giuseppe Minniti, Dr. · EORTC Study Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2027-09-30
Completion
2028-02-29

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904119 on ClinicalTrials.gov