2024-515384-62-00招募中3 期
Interest of peri operative CHemotherapy In patients with CINSARC high-risk localized Soft Tissue Sarcoma
Oncopole Claudius Regaud19 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年6月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- The primary endpoint is Metastasis-free survival (MFS). MFS is defined by the delay between randomization and the appearance of metastatic disease or death from any cause.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
The primary endpoint is Metastasis-free survival (MFS). MFS is defined by the delay between randomization and the appearance of metastatic disease or death from any cause.
The primary endpoint is Metastasis-free survival (MFS). MFS is defined by the delay between randomization and the appearance of metastatic disease or death from any cause.
次要结局
- Disease-free survival (DFS) is defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause. Patients still alive at the time of analysis (including lost to follow-up) without appearance of relapse will be censored at the last disease assessment date.
- Overall survival (OS) is defined by the delay between randomization and death from any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date.
- Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).
研究者
Dr Thibaud VALENTIN
Scientific
Oncopole Claudius Regaud
研究点 (19)
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