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Adding chemotherapy to surgery for high-risk localized soft tissue sarcoma

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

PHASE3 · Institut Claudius Regaud · NCT04307277

This study is testing if adding chemotherapy to surgery can help people with high-risk localized soft tissue sarcoma live longer without their cancer spreading.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorInstitut Claudius Regaud (other)
Drugs / interventionscyclophosphamide, Doxorubicin, chemotherapy
Locations19 sites (Besançon and 18 other locations)
Trial IDNCT04307277 on ClinicalTrials.gov

What this trial studies

This Phase III, multicenter, randomized open-label study aims to evaluate the effectiveness of adding four cycles of peri-operative doxorubicin-based chemotherapy to standard management in patients with high-risk localized soft tissue sarcoma, as determined by the CINSARC signature. Eligible patients will undergo molecular screening, and those identified as high-risk will be randomly assigned to either receive standard care or the experimental chemotherapy regimen. The primary goal is to improve metastasis-free survival compared to standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed resectable localized soft tissue sarcoma classified as high-risk according to the CINSARC signature.

Not a fit: Patients with low-risk soft tissue sarcoma or those with unresectable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance survival outcomes for patients with high-risk localized soft tissue sarcoma.

How similar studies have performed: Previous studies have indicated that chemotherapy can improve outcomes in sarcoma treatment, suggesting potential success for this approach, although this specific methodology is being tested in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
2. According to FNCLCC grading system, grade 1, 2 or 3 tumors
3. Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)
4. 6 weeks or less between surgical excision and inclusion (if performed before inclusion)
5. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification
6. Age ≥ 18 years
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
8. Life expectancy of at least 12 weeks after the start of the treatment
9. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period and at least 12 months (ifosfamide treatment) or 6 months (dacarbazine treatment) after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study treatment.
10. Signed written informed consent
11. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma
2. Primitive cutaneous, retroperitoneal, uterus or visceral STS
3. Metastatic disease
4. Previous or ongoing treatment for the sarcoma (with the exception of surgical excision)
5. Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments
6. Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines
7. Prior mediastinal/cardiac radiotherapy
8. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry
9. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma
10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
11. Known infection with HIV, hepatitis B, or hepatitis C
12. Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial
13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
14. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
15. Patient unable to comply with the protocol for any reason.

ADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY

1. High-risk CINSARC signature
2. Acceptable hematologic function (within 72 hours prior randomization): Absolute neutrophil count (ANC) ≥ 1.5 G/L, Platelet count ≥ 100 G/L and Hemoglobin \> 9g/dL
3. Acceptable renal function within 72 hours prior randomization: Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (by the Cockcroft and Gault formula)
4. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
5. Normal LVEF (\>50%) measured by echocardiography or isotopic ventriculography

Where this trial is running

Besançon and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Soft Tissue Sarcoma, CINSARC signature, Chemotherapy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.