OncoMatch/Clinical Trials/NCT04031677
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Is NCT04031677 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Preoperative chemotherapy for retroperitoneal sarcoma.
Treatment: Preoperative chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: MDM2 expression
Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.
Required: CDK4 expression
Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.
Performance status
WHO 0–2
Prior therapy
Cannot have received: surgery
Exception: diagnostic biopsy
Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
Cannot have received: radiotherapy
Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
Cannot have received: systemic therapy
Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
Cannot have received: anthracycline (doxorubicin, daunorubicin, epirubicin, idarubicin)
Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent 900mg/m² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
Lab requirements
Blood counts
Adequate haematological function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Cardiac function
American Society of Anaesthesiologist (ASA) score < 3
Adequate haematological and organ function; American Society of Anaesthesiologist (ASA) score < 3
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- City of Hope Comprehensive Cancer Center · Duarte, California
- UCI Health-Chao Family Comp CC and Ambulatory Care · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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