2023-509489-39-00招募中3 期
CIRSARC : PHASE III TRIAL INVESTIGATING BENEFIT OF INTENSIFIED PERI-OPERATIVE CHEMOTHERAPY WITHIN HIGH-RISK CINSARC PATIENTS WITH RESECTABLE SOFT-TISSUE SARCOMAS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 351
- 试验地点
- 9
- 主要终点
- Metastasis progression-free survival (M-PFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014).
研究概览
简要总结
The 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).
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
- •Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,
- •Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year,
- •Voluntarily signed and dated written informed consents prior to any study specific procedure,
- •Patients with a social security in compliance with the French law.
- •Grade 2 or 3 according to the FNCLCC grading system,
- •Available archived tumour sample for research purpose,
- •Non-metastatic and resectable disease,
- •No prior treatment for the disease under study,
- •Age ≥ 18 years,
- •Life expectancy ≥ 3 months,
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
- •Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy,
排除标准
- •Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, embryonal and alveolar rhabdomyosarcoma,
- •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,
- •Any other contraindication to anthracycline, ifosfamide or dacarbazine,
- •Participation to a study involving a medical or therapeutic intervention in the last 28 days,
- •Known infection with HIV, hepatitis B, or hepatitis C,
- •Females who are pregnant or breast-feeding,
- •Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,
- •Individuals deprived of liberty or placed under legal guardianship,
- •Unwillingness or inability to comply with the study protocol for any reason.
结局指标
主要结局
Metastasis progression-free survival (M-PFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014).
Metastasis progression-free survival (M-PFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014).
次要结局
- Loco-regional relapse-free survival (LR-RFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or loco-regional progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2015). Progression-free survival is defined as the time interval between the randomization date and the date of death (whatever the cause) or progression (as per RECIST v1.1), whichever occurs first.
- Overall survival is defined as the time interval between the randomization date and the date of death (whatever the cause).
- Best overall response is defined as the best response recorded from randomization until the end of neoadjuvant chemotherapy taking into account any requirement for confirmation as per RECIST v1.1 criteria
- Histological response is defined based on tumour sample as the average proportion of recognizable cells on the tumour sample [Huvos et al, Arch Pathol Lab Med 1977]. Good histological response is defined as <10% viable cells on the tumour sample.
- Safety will be described using the common toxicity criteria from the NCI v5.
研究者
Pr Antoine Italiano
Scientific
Institut Bergonie
研究点 (9)
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