Authorised Therapeutic confirmatory (Phase III) Soft Tissue Sarcoma

Interest of peri operative CHemotherapy In patients with CINSARC highrisk localized Soft Tissue Sarcoma.

EU CTIS ID: 2024-515384-62-00

What this study is testing

The primary objective of this study is 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.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1.Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
10.Signed written informed consent
11.Patient affiliated to a Social Health Insurance in France
1.High-risk CINSARC signature (FOR THE RANDOMIZED PHASE III STUDY)
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)

You likely can't join if

1.Soft-tissue sarcoma with the following histological subtypes: welldifferentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma
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)

See the full eligibility criteria

Who can join

1.Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
10.Signed written informed consent
11.Patient affiliated to a Social Health Insurance in France
1.High-risk CINSARC signature (FOR THE RANDOMIZED PHASE III STUDY)
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
2.According to FNCLCC grading system, grade 1, 2 or 3 tumors
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.

What rules you out

1.Soft-tissue sarcoma with the following histological subtypes: welldifferentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma
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
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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.