Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05904119 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: LEGATO
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 43 to 45v19
  2. Study sites: 42 to 43v18
  3. Study sites: 40 to 42v17
  4. Study sites: 39 to 40v16
  5. Study sites: 37 to 39v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 36 to 37v14
  2. Study sites: 34 to 36v13
  3. Study sites: 33 to 34v12
  4. Study sites: 32 to 33v11
  5. Study sites: 31 to 32v10
  6. Study sites: 29 to 31v9
  7. Study sites: 27 to 29v8
  8. Study sites: 25 to 27v7
  9. Study sites: 23 to 25v6
  10. Study sites: 18 to 23v5
  11. Study sites: 16 to 18v4
  12. Study sites: 7 to 16
    • Collaborators expanded, about 3 words
    v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Mar 2024 to Mar 15, 2024
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT05904119
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Swiss Cancer Institute
Conditions
(from sponsor)		 First Progression of Glioblastoma
Related terms Glioblastoma
Enrollment 411 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov