Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Feb 1, 2027 → Oct 14, 2028
See other at-risk trials from Alliance for Clinical Trials in Oncology

Record History

The 50 most recent of 61 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 1, 2027 to Oct 14, 2028 Show 5 more changesShow less
    • Study completion pushed from Feb 1, 2029 to Oct 14, 2030
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Study description shortened, about 15 words
    • Site details revised at 26 of 424 sites
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment reduced: 271 → 237 participants
    • Site details revised at 424 of 424 sites
    v60
  3. Study sites: 423 to 424v59
  4. Re-verified, no change to tracked fieldsv58
  5. Study sites revised (423)v57
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 15 of 423 sitesv56
  2. Study sites: 422 to 423v55
  3. Study sites: 420 to 422v54
  4. Study sites: 414 to 420v53
  5. Study sites revised (414)v52
  6. Start date: Aug 1, 2018 to Dec 10, 2018
    • Primary completion date: Feb 2027 to Feb 1, 2027
    • Study completion date: Feb 2029 to Feb 1, 2029
    • Site details revised at 276 of 414 sites
    v51
  7. Study sites: 411 to 414v50
  8. Study sites: 410 to 411v49
  9. Study sites: 409 to 410v48
  10. Study sites: 408 to 409v47
  11. Study sites: 407 to 408v46
  12. Study sites: 405 to 407v45
  13. Study sites: 404 to 405v44
  14. Study sites: 401 to 404v43
  15. Study sites: 390 to 401v42
  16. Study sites revised (390)v41
  17. Site details revised at 12 of 390 sitesv40
  18. Study sites: 389 to 390v39
  19. Study sites: 387 to 389v38
  20. Study sites: 384 to 387v37
  21. Study sites: 372 to 384v36
  22. Study sites: 371 to 372v35
  23. Site details revised at 18 of 371 sitesv34
  24. Site details revised at 14 of 371 sitesv33
  25. Study sites: 370 to 371v32
  26. Study sites: 367 to 370v31
  27. Study sites: 366 to 367v30
  28. Study sites: 364 to 366v29
  29. Study sites: 360 to 364v28
  30. Eligibility criteria expanded, about 60 words
    • Study description expanded, about 28 words
    • Site details revised at 11 of 360 sites
    v27
  31. Study title shortened, about 2 wordsv26
  32. Study sites: 358 to 360v25
  33. Study sites revised (358)v24
  34. Study sites: 357 to 358v23
  35. Site details revised at 5 of 357 sitesv22
  36. Study sites: 356 to 357v21
  37. Study sites: 355 to 356v20
  38. Study sites: 354 to 355v19
  39. Study sites: 353 to 354v18
  40. Study sites: 351 to 353v17
  41. Study sites: 350 to 351v16
  42. Study sites: 335 to 350v15
  43. Study sites: 328 to 335v14
  44. Study sites: 315 to 328v13
  45. Study sites: 305 to 315v12
  • 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 phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Trial Details
NCT Number NCT03609216
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma
Enrollment 237 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov