PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

Study acronym: PRIMALung
StatusRecruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 41 → 55 locations
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description expanded, about 13 words
  2. Site details revised at 2 of 41 sitesv19
  3. Site details revised at 2 of 41 sitesv18
  4. Study sites: 42 to 41v17
  5. Site details revised at 2 of 42 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 43 to 42v15
  2. Study sites: 41 to 43v14
  3. Site details revised at 1 of 41 sitesv13
  4. Study sites: 42 to 41v12
  5. Study sites: 41 to 42v11
  6. Secondary endpoints: details revised at 2 of 3 entriesv10
  7. Study sites revised (41)v9
  8. Study sites: 38 to 41v8
  9. Site details revised at 1 of 38 sitesv7
  10. Site details revised at 2 of 38 sitesv6
  11. Site details revised at 1 of 38 sitesv5
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2022 to Oct 27, 2022
    • Site details revised at 38 of 38 sites
    v4
  13. Start date: Jul 2022 to Oct 2022
    • Site contacts updated at 1 of 38 sites
    v3
  14. Phase: Phase 3 to Not applicable
    • Start date: Sep 2021 to Jul 2022
    • Study sites: 0 to 38
    • Primary and study completion dates: Nov 2027 to Apr 2028
    v2
  1. Study First Submitted
  • 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.
In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.
Trial Details
NCT Number NCT04790253
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: UNICANCER
Conditions
(from sponsor)		 Limited Stage Small Cell Lung Cancer, Extensive-stage Small-cell Lung Cancer
Related terms Small Cell Lung Carcinoma
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov