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Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas

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

Record History

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  1. Primary completion date: Feb 2025 to Dec 2026
    • Study completion date: Feb 2025 to Dec 2028
    v7
  2. Site details revised at 1 of 10 sitesv6
  3. Interventions: At the discretion of the investigator (Drug), Doxorubicin (Drug), Doxorubicin (Drug), Ifosfamide (Drug), Ifosfamide (Drug) to At the discretion of the investigator (Drug), Doxorubicin (Drug), Doxorubicin (Drug), Ifosfamide or dacarbazine (Drug), Ifosfamide or…
    • Study sites revised (10)
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 4 words
    v5
  4. Site details revised at 1 of 10 sitesv4
  5. Enrollment target: 334 to 351
    • Eligibility criteria revised
    • Site details revised at 4 of 10 sites
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2019 to Feb 14, 2019
    • Site details revised at 10 of 10 sites
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Bergonié
40 trials monitored
See 1 trial at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
Trial Details
NCT Number NCT03805022
Lead Sponsor Institut Bergonié
Collaborators: Novartis, Chugai Pharma France
Conditions
(from sponsor)		 Non-metastatic Soft-tissue Sarcoma, Resectable
Related terms Sarcoma
Enrollment 351 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov