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OncoMatch/Clinical Trials/NCT03805022

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

Is NCT03805022 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for non-metastatic soft-tissue sarcoma.

Phase 3RecruitingInstitut BergoniéNCT03805022Data as of May 2026

Treatment: Doxorubicin · Ifosfamide or dacarbazine · Doxorubicin · Ifosfamide or dacarbazine · At the discretion of the investigatorThe 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).

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Extracted eligibility criteria

Cancer type

Sarcoma

Disease stage

Grade: 23 (fnclcc)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anthracycline-based chemotherapy

Exception: no more than two cycles of neo-adjuvant anthracycline-based chemotherapy before randomization

No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before randomization

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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