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Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 122 to 123
  2. Study sites: 121 to 122
  3. Trial sites expanded: 118 → 121 locations
    • Interventions: Adjuvant radiotherapy (EBRT +/- brachytherapy) (Radiation), Observation (Other), Vaginal brachytherapy (Radiation) to Adjuvant radiotherapy (EBRT +/- brachytherapy) (Radiation), Observation (Other), Vaginal brachytherapy (Radiation)
    • Eligibility criteria expanded, about 15 words
  4. Collaborators: 7 to 8v42
  5. Trial sites expanded: 114 → 118 locationsv41
  6. Trial sites expanded: 110 → 114 locationsv40
  7. Study sites: 108 to 110v39
  8. Trial sites expanded: 105 → 108 locationsv38
  9. Collaborators: 1 to 7v37
  10. Trial sites expanded: 100 → 105 locationsv36
  11. Study sites: 96 to 100v35
  12. Study sites: 92 to 96v34
  13. Study sites: 91 to 92v33
  14. Study sites: 88 to 91v32
  15. Study sites: 87 to 88v31
  16. Study sites: 85 to 87v30
  17. Study sites: 77 to 85v29
  18. Study sites: 67 to 77v28
  19. Study sites: 64 to 67v27
  20. Study sites: 59 to 64v26
  21. Enrollment target: 325 to 393
    • Eligibility criteria expanded, about 16 words
    v25
  22. Study sites: 52 to 59v24
  23. Study sites: 45 to 52v23
  24. Study sites: 42 to 45v22
  25. Study sites: 38 to 42v21
  26. Study sites: 31 to 38v20
  27. Study sites: 26 to 31v19
  28. Study sites: 24 to 26v18
  29. Study sites: 23 to 24v17
  30. Re-verified, no change to tracked fieldsv16
  31. Study sites: 19 to 23v15
  32. Study sites: 10 to 19v14
  33. Re-verified, no change to tracked fieldsv13
  34. Study sites: 9 to 10v12
  35. Study sites: 8 to 9v11
  36. Site details revised at 1 of 8 sitesv10
  37. Secondary endpoints: 8 to 7v9
  38. Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (8)
    v8
  39. Study sites: 7 to 8v7
  40. Study sites: 5 to 7v6
  41. Study sites: 4 to 5v5
  42. Study sites: 1 to 4v4
  43. Site details revisedv3
  44. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 2028 to Dec 31, 2028
    • Study completion date: Jun 2029 to Jun 30, 2029
    • Start date changed from estimate of Dec 2022 to Dec 19, 2022
    • Study description revised
  45. 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 protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies * EN10.A/RAINBO BLUE: POLE-mutated EC * EN10.B/TAPER: p53 wildtype / NSMP EC
Trial Details
NCT Number NCT05640999
Lead Sponsor Canadian Cancer Trials Group
Collaborators: Canadian Cancer Clinical Trials Network, Australia New Zealand Gynaecological Oncology Group, Gustave Roussy, Cancer Campus, Grand Paris, Leiden University Medical Center, Mario Negri Gynecologic Oncology group (MaNGO), NRG Oncology, Philipps University Marburg, University College, London
Conditions
(from sponsor)		 Endometrial Cancer
Related terms Endometrial Neoplasms
Enrollment 393 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov