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Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 69 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (629)v69 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (629)v68 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 630 to 629v67
  4. Secondary endpoints revised (3) Site details revised at 4 of 630 sitesv66 Show 1 more changeShow less
    • Site details revised at 4 of 630 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv65
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 629 to 630 Interventions: Best Practice (Other), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin… to Best Practice (Other), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin… · Study description expanded, about 29 wordsv64 Show 2 more changesShow less
    • Interventions: Best Practice (Other), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin… to Best Practice (Other), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin…
    • Study description expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (629)v63 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (629)v62 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (629)v61 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 626 to 629v60
  6. Study sites revised (626)v59 See this version in full on ClinicalTrials.gov ↗
  7. Enrollment target: 2097 to 1780 Study sites: 620 to 626 · Interventions: Best Practice (Other), Biopsy (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin (Drug)… to Best Practice (Other), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin… · Eligibility criteria expanded, about 17 words · 2 morev58 Show 5 more changesShow less
    • Study sites: 620 to 626
    • Interventions: Best Practice (Other), Biopsy (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin (Drug)… to Best Practice (Other), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin…
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 98 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites revised (620)v57 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (620)v56 See this version in full on ClinicalTrials.gov ↗
  10. Study sites revised (620)v55 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 618 to 620v54
  12. Study sites: 609 to 618v53
  13. Study sites: 604 to 609v52
  14. Study sites revised (604)v51 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 603 to 604 Eligibility criteria shortened, about 8 words · Study description expanded, about 1 wordv50 Show 2 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites revised (603)v49 See this version in full on ClinicalTrials.gov ↗
  17. Enrollment target: 2059 to 2097 Site details revised at 16 of 603 sitesv48 Show 1 more changeShow less
    • Site details revised at 16 of 603 sites
  18. Study sites: 596 to 603v47
  19. Study sites: 593 to 596v46
  20. Study sites: 592 to 593 Start date: May 8, 2017 to May 25, 2017v45 Show 1 more changeShow less
    • Start date: May 8, 2017 to May 25, 2017
  21. Study sites: 589 to 592v44
  22. Study sites revised (589)v43 See this version in full on ClinicalTrials.gov ↗
  23. Study sites: 588 to 589v42
  24. Study sites: 587 to 588v41
  25. Study sites: 586 to 587v40
  26. Study sites: 580 to 586v39
  27. Study sites: 578 to 580v38
  28. Study sites: 576 to 578v37
  29. Study sites: 575 to 576v36
  30. Site contacts updated at 1 of 575 sitesv35
  31. Study description expanded, about 10 words Study sites revised (575)v34 Show 1 more changeShow less
    • Study sites revised (575)

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 570 to 575 Interventions: Best Practice (Other), Bleomycin Sulfate (Biological), Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Laboratory Biomarker… to Best Practice (Other), Biopsy (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin (Drug)… · Eligibility criteria expanded, about 36 words · Study description expanded, about 167 wordsv33 Show 3 more changesShow less
    • Interventions: Best Practice (Other), Bleomycin Sulfate (Biological), Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Laboratory Biomarker… to Best Practice (Other), Biopsy (Procedure), Biospecimen Collection (Procedure), Bleomycin Sulfate (Biological), Carboplatin (Drug)…
    • Eligibility criteria expanded, about 36 words
    • Study description expanded, about 167 words

    See this version in full on ClinicalTrials.gov ↗

  33. Site details revised at 13 of 570 sitesv32
  34. Study sites: 568 to 570v31
  35. Study sites: 567 to 568v30
  36. Study sites: 566 to 567v29
  37. Interventions: Best Practice (Other), Bleomycin (Drug), Bleomycin Sulfate (Biological), Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Etoposide… to Best Practice (Other), Bleomycin Sulfate (Biological), Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Laboratory Biomarker… Eligibility criteria expanded, about 7 words · Secondary endpoints revised (2) · Site details revised at 21 of 566 sites · 2 morev28 Show 5 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (2)
    • Site details revised at 21 of 566 sites
    • Study title revised
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  38. Study sites: 558 to 566v27
  39. Study sites: 556 to 558v26
  40. Study sites: 555 to 556v25
  41. Site contacts updated at 5 of 555 sitesv24
  42. Site details revised at 11 of 555 sitesv23
  43. Study sites: 546 to 555v22
  44. Study sites revised (546)v21 See this version in full on ClinicalTrials.gov ↗
  45. Study sites: 530 to 546v20
  • 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 phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
Trial Details
NCT Number NCT03067181
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7 +22 more
Enrollment 1,780 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov