JPRN-jRCTs031230482招募中3 期
JCOG2214INT: A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma - STRASS 2
OZAKI Toshifumi0 个研究点目标入组 250 人开始时间: 2023年11月28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
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •* Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis (LPS: Grade 3 DDLPS OR confirmed Grade 2 DDLPS on biopsy only if FNCLCC score = 5 AND clear necrosis on imaging. LMS: Any grade and size > 5 cm)
- •* Unifocal tumour
- •* Resectable tumour
- •* Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging within the 28 days prior to randomization.
- •* Collection of tumor tissue and blood samples for central pathology review and translational research are mandatory.
- •* >= 18 years old (no upper age limit)
- •* WHO performance status <= 2
- •* Adequate haematological and organ function assessed within 21 days prior to randomization
- •* American Society of Anaesthesiologist (ASA) score < 3
- •* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.
- •* For men in the experimental arm: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm.
- •* Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •* Sarcoma originating from bone structure, abdominal or gynecological viscera
- •* Extension through the sciatic notch or across the diaphragm
- •* Metastatic disease
- •* Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
- •* Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
- •* Congestive heart failure
- •* Angina pectoris
- •* Myocardial infarction within 1 year before randomization
- •* Uncontrolled arterial hypertension defined as blood pressure >= 150/100 mm Hg despite optimal medical therapy
- •* Uncontrolled cardiac arrhythmia
- •* 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
- •* Active and uncontrolled infections
- •* Vaccination with live vaccines within 30 days prior to study entry
- •* Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
- •* Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason <= 6prostate cancer.
- •* Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.
- •* Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.
- •* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
- •* Known contraindication to imaging tracer and to MRI
研究者
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