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Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Study acronym: STRASS2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 175 to 176 Show 4 more changesShow less
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: details revised at 3 of 13 entries
    • Study description expanded, about 6 words
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 169 → 175 locationsv28
  3. Trial sites expanded: 164 → 169 locationsv27
  4. Site details revised at 7 of 164 sitesv26
  5. Study sites: 149 to 164v25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 147 to 149v24
  2. Study sites: 145 to 147v23
  3. Study sites: 136 to 145v22
  4. Study sites: 133 to 136
    • Eligibility criteria expanded, about 199 words
    • Secondary endpoints: 4 to 13
    v21
  5. Study sites: 123 to 133v20
  6. Study sites: 120 to 123v19
  7. Study sites: 99 to 120v18
  8. Study sites: 73 to 99v17
  9. Study sites: 62 to 73v16
  10. Study sites: 57 to 62v15
  11. Study sites: 43 to 57v14
  12. Site details revised at 1 of 43 sitesv13
  13. Study sites: 40 to 43v12
  14. Collaborators: 4 to 5v11
  15. Study sites: 37 to 40
    • Collaborators revised (4)
    v10
  16. Start date: Oct 6, 2020 to Jan 20, 2021
    • Study sites: 23 to 37
    • Study title revised
    • Eligibility criteria shortened, about 3 words
    v9
  17. Study sites: 6 to 23
    • Collaborators: 3 to 4
    v8
  18. Collaborators: 2 to 3v7
  19. Study sites: 1 to 6v6
  20. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 15, 2020 to Oct 6, 2020
    v5
  21. Start date: Jul 1, 2020 to Oct 15, 2020v4
  22. Start date: Apr 21, 2020 to Jul 1, 2020
    • Collaborators expanded, about 7 words
    v3
  23. Eligibility criteria expanded, about 26 words
    • Study description expanded, about 69 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Trial Details
NCT Number NCT04031677
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, Anticancer Fund, Belgium, Australia and New Zealand Sarcoma Association, Japan Clinical Oncology Group
Conditions
(from sponsor)		 Retroperitoneal Sarcoma, Liposarcoma, Leiomyosarcoma
Related terms Leiomyosarcoma, Liposarcoma
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov