Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05304585 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 180 to 181v43
  2. Study sites: 179 to 180v42
  3. Study sites: 177 to 179v41
  4. Study sites revised (177)v40 See this version in full on ClinicalTrials.gov ↗
  5. Site contacts updated at 1 of 177 sitesv39
Show 37 earlier versionsHide 37 earlier versions
  1. Study sites: 175 to 177 Interventions: Biopsy (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Cyclophosphamide (Drug), Dactinomycin (Biological), Magnetic… to Biopsy Procedure (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Cyclophosphamide (Drug), Dactinomycin (Biological)…v38 Show 1 more changeShow less
    • Interventions: Biopsy (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Cyclophosphamide (Drug), Dactinomycin (Biological), Magnetic… to Biopsy Procedure (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Cyclophosphamide (Drug), Dactinomycin (Biological)…
  2. Study sites: 174 to 175v37
  3. Study sites revised (174)v36 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 171 to 174v35
  5. Study sites: 167 to 171v34
  6. Study sites: 164 to 167v33
  7. Study sites: 158 to 164v32
  8. Study sites: 156 to 158v31
  9. Study sites: 154 to 156v30
  10. Study sites: 153 to 154v29
  11. Primary and study completion dates: Dec 31, 2030 to Jun 30, 2030v28
  12. Site details revised at 1 of 153 sitesv27
  13. Study sites: 151 to 153 Eligibility criteria expanded, about 37 wordsv26 Show 1 more changeShow less
    • Eligibility criteria expanded, about 37 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 150 to 151v25
  15. Study sites: 147 to 150v24
  16. Study sites: 141 to 147v23
  17. Study sites: 139 to 141v22
  18. Study sites: 137 to 139v21
  19. Start date: Jun 22, 2022 to Aug 4, 2022 Study sites: 135 to 137 · Primary and study completion dates: Mar 31, 2031 to Dec 31, 2030v20 Show 2 more changesShow less
    • Study sites: 135 to 137
    • Primary and study completion dates: Mar 31, 2031 to Dec 31, 2030
  20. Study sites: 118 to 135v19
  21. Study sites: 114 to 118v18
  22. Study sites: 105 to 114v17
  23. Study sites: 88 to 105 Interventions: Cyclophosphamide (Drug), Dactinomycin (Biological), Radiation Therapy (Radiation), Vincristine (Drug) to Biopsy (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Cyclophosphamide (Drug), Dactinomycin (Biological), Magnetic… · Study description shortened, about 17 wordsv16 Show 2 more changesShow less
    • Interventions: Cyclophosphamide (Drug), Dactinomycin (Biological), Radiation Therapy (Radiation), Vincristine (Drug) to Biopsy (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Cyclophosphamide (Drug), Dactinomycin (Biological), Magnetic…
    • Study description shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  24. Primary and study completion dates: Mar 31, 2035 to Mar 31, 2031v15
  25. Primary and study completion dates: Dec 30, 2041 to Mar 31, 2035 Study sites: 86 to 88v14 Show 1 more changeShow less
    • Study sites: 86 to 88
  26. Study sites: 81 to 86v13
  27. Study sites: 70 to 81v12
  28. Study sites: 60 to 70v11
  29. Study sites: 53 to 60v10
  30. Primary and study completion dates: Jun 30, 2030 to Dec 30, 2041 Study sites: 49 to 53v9 Show 1 more changeShow less
    • Study sites: 49 to 53
  31. Study sites: 48 to 49 Study description expanded, about 13 wordsv8 Show 1 more changeShow less
    • Study description expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 23 to 48v7
  33. Primary endpoints revised (2) Enrollment target: 195 to 205 · Study sites: 10 to 23 · Eligibility criteria shortened, about 52 words · 2 morev6 Show 5 more changesShow less
    • Enrollment target: 195 to 205
    • Study sites: 10 to 23
    • Eligibility criteria shortened, about 52 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  34. Study sites: 5 to 10 Start date changed from estimate of Jun 28, 2022 to Jun 22, 2022v5 Show 1 more changeShow less
    • Start date changed from estimate of Jun 28, 2022 to Jun 22, 2022
  35. Study sites: 1 to 5v4
  36. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  37. Secondary endpoints revised (3) Study description revisedv2 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  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.
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Trial Details
NCT Number NCT05304585
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Embryonal Rhabdomyosarcoma, Fusion-Negative Alveolar Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov