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Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma

Study acronym: CHIC-STS01
StatusRecruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 19 to 20
    • Eligibility criteria expanded, about 31 words
    • Publications: details revised at 1 of 1 entry
  2. Eligibility criteria expanded, about 6 wordsv17
  3. Publications: details revised at 1 of 1 entryv16
  4. Study sites: 22 to 19v15
  5. Site details revised at 2 of 22 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Primary and study completion dates: Mar 2025 to Oct 2032
    • Eligibility criteria expanded, about 37 words
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Site details revised at 1 of 22 sitesv10
  5. Eligibility criteria shortened, about 8 words
    • Study sites revised (22)
    v9
  6. Eligibility criteria revised
    • Study title shortened, about 4 words
    v8
  7. Site contacts updated at 2 of 22 sitesv7
  8. Site details revised at 1 of 22 sitesv6
  9. Study sites: 21 to 22v5
  10. Study sites: 19 to 21v4
  11. Study sites: 17 to 19v3
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2020 to Oct 9, 2020
    • Study sites: 11 to 17
    • Eligibility criteria expanded, about 1 word
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Institut Claudius Regaud
76 trials monitored
See 4 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature. After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened). Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort). Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms: * Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy). * Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks. A total of 250 patients will have to be randomized with 125 patients in each arm.
Trial Details
NCT Number NCT04307277
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 Soft Tissue Sarcoma
Related terms Sarcoma
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov