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Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy

Study acronym: BLAD-RAD01
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv20
  2. Primary and study completion dates: Jul 2028 to Jul 2031
    • Study sites: 19 to 20
    v19
  3. Eligibility criteria expanded, about 20 wordsv18
  4. Site details revised at 1 of 19 sitesv17
  5. Study sites: 18 to 19v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary and study completion dates: Jul 2023 to Jul 2028
    • Site details revised at 2 of 18 sites
    v15
  2. Study sites: 17 to 18v14
  3. Site details revised at 2 of 17 sitesv13
  4. Study sites: 15 to 17v12
  5. Study sites: 14 to 15v11
  6. Eligibility criteria expanded, about 2 wordsv10
  7. Site details revised at 1 of 14 sitesv9
  8. Site details revised at 1 of 14 sitesv8
  9. Study sites: 13 to 14v7
  10. Study sites: 12 to 13v6
  11. Site details revised at 4 of 12 sitesv5
  12. Site details revised at 2 of 12 sites
    • Eligibility criteria expanded, about 5 words
    v4
  13. Enrollment target: 100 to 130v3 Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 2 of 12 sites
    • Study title shortened, about 2 words
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2020 to Jun 30, 2020
    • Site details revised at 12 of 12 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II, multicenter, randomized open-label and comparative study that has been designed to evaluate whether local consolidative radiotherapy in addition to standard of care improves overall survival as compared with standard of care in patients with regional and/or distant metastatic urothelial bladder cancer who have no disease progression and with no more than three residual distant metastatic lesions following the initial phase of first-line systemic therapy. Each patient will be followed during 4 years from the date of randomization.
Trial Details
NCT Number NCT04428554
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 Urothelial Bladder Cancer
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov