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Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas

Study acronym: SCOPES
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from May 1, 2031 to May 1, 2036 Primary completion date changed from estimate of May 1, 2026 to May 13, 2026 · Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 2 of 3 entries Show 3 more changesShow less
    • Primary completion date changed from estimate of May 1, 2026 to May 13, 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 4 of 4 sitesv12 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  3. Primary completion date: Apr 1, 2025 to May 1, 2026 Enrollment target: 163 to 168 · Completion date: Apr 1, 2034 to May 1, 2031 · Secondary endpoints: 2 to 3v11 Show 3 more changesShow less
    • Enrollment target: 163 to 168
    • Completion date: Apr 1, 2034 to May 1, 2031
    • Secondary endpoints: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Study Identification, Study Status, Oversight, Contacts/Locationsv10
  5. Phase: Phase 2 to Not applicablev9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 3 to 4v8
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 3 · Start date changed from estimate of Apr 1, 2021 to Jun 25, 2021v6 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Apr 1, 2021 to Jun 25, 2021
  4. Re-verified, no change to tracked fieldsv5
  5. Enrollment target: 102 to 163 Primary completion date: Aug 1, 2024 to Apr 1, 2025 · Start date: Jan 1, 2021 to Apr 1, 2021 · Primary endpoint revised · 6 morev4 Show 9 more changesShow less
    • Primary completion date: Aug 1, 2024 to Apr 1, 2025
    • Start date: Jan 1, 2021 to Apr 1, 2021
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Completion date: Aug 1, 2032 to Apr 1, 2034
    • Eligibility criteria shortened, about 9 words
    • Study description expanded, about 102 words
    • Study title expanded, about 6 words
    • Study arms: 0 to 2

    See this version in full on ClinicalTrials.gov ↗

  6. Start date: Aug 1, 2020 to Jan 1, 2021v3
  7. Study description shortened, about 2 wordsv2 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.
Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Within this study, patients will be randomized to receive either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication rate until 30 days after surgery, as well as the local control probability at two years are comparable in both arms.
Trial Details
NCT Number NCT04425967
Lead Sponsor The Netherlands Cancer Institute
Collaborators: Leiden University Medical Center
Conditions Soft Tissue Sarcomas
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov