EUCTR2019-003543-30-CZ进行中（未招募）1 期
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma - STRASS 2
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 250 人开始时间: 2020年7月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 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.
- •- LMS: * Grades 2 and 3 LMS of minimum size 5 cm
- •- LPS (diagnosis based on MDM2 and CDK4 expression on
- •IHC; additional proof of MDM2 amplification is highly
- •recommended but not mandatory):
- •* Grade 3 DDLPS OR
- •* Confirmed grade 2 DDLPS on biopsy only if:
- •FNCLCC score = 5 AND no necrosis on the biopsy but
- •clear necrosis on imaging. OR
- •* High risk gene profile as determined by the Complexity
- •INdex in SARComas (CINSARC-high)
- •Unifocal tumour
- •Resectable tumour: resectability is based on pre-operative imaging
- •performed within 28 days before randomization (CT-abdomen,
- •potentially also with MRI) and has to be defined by the local
- •treating sarcoma team. A patient is not considered resectable when
- •the expectation is that only an R2 resection is feasible.
- •Criteria for non-resectability are:
- •- Involvement of the superior mesenteric artery, aorta,
- •coeliac trunk and/or portal vein
- •- Involvement of bone
- •- Growth into the spinal canal
- •- Progression of retro-hepatic inferior vena cava
- •leimyosarcoma towards the right atrium
- •- Infiltration of multiple major organs like liver, pancreas
- •and or major vessels
- •Patient must have radiologically measurable disease (RECIST 1.1),
- •as confirmed by imaging within the 28 days prior to
- •randomization. CT thorax abdomen pelvis with IV contrast is the
- •preferred imaging modality. In case of any contra-indications
- •(medical or regulatory), it is allowed to perform a non-contrast CT
- •thorax + MRI abdomen & pelvis.
- •= 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 Anesthesiologist (ASA) score < 3
- •Women of child bearing potential (WOCBP) must have a negative
- •serum pregnancy test within 3 days prior to randomization.
- •WOCBP in both arms should use higly effective birth control
- •measures, during the study treatment period and for at least 6
- •months after the last dose of chemotherapy or date of surgery
- •(except for women receiving chemotherapy with ifosfamide who
- •should continue contraception until 1 year after last day of
- •treatment). A highly effective method of birth control is defined as
- •a method which results in a low failure rate (i.e. less than 1% per
- •year) when used consistently and correctly.
- •For men in the experimental arm: agreement to remain abstinent
- 另有 16 项未显示
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 = 6 prostate 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 pateints 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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