EUCTR2010-023484-17-PL进行中（未招募）1 期
OCALIZED HIGH-RISK SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND TRUNK WALL IN ADULTS: AN INTEGRATING APPROACH COMPRISING STANDARD VS HISTOTYPE-TAILORED NEOADJUVANT CHEMOTHERAPY (ISG-STS 10-01)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •Soft tissue sarcoma of adults, primary or locally recurrent, with spindle-cell or pleomorphic histology, belonging to one of the following for the randomization (Group1):
- •?Myxoid-Round Cell liposarcoma (cellular component >5 %)
- •?Leiomyosarcoma
- •?Synovial sarcoma
- •?Malignant Peripheral Nerve Sheat Tumor
- •?Undifferentiated pleomorphic sarcoma (ex Malignant fibrous histiocytoma)
- •Or belonging to one of the following for the registration (Group 2):
- •?Myxofibrosarcoma
- •?Unclassified Spindle Cell
- •?Pleomorphic Liposarcoma
- •?Pleomorphic Rabdomiosarcoma
- •Or belonging to either group but not being evaluable for response (re-excision after previous inadequate resection or primary definitive surgery) (Group3).
- •The histological diagnosis must be made according to the WHO criteria (19) and will have to be centrally reviewed before randomization.
- •2)High malignancy grade: grade 3 of 3, according to Coindre (20), or grade 2 at biopsy with a radiological evidence of more than 50% of necrosis in the tumor mass.
- •3)Deep seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) lesion.
- •4)Size of primary tumor (visible or previously inadequately resected) >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size.
- •5)Age > 18 years.
- •6)ECOG performance status <1 (21).
- •7)Adequate bone marrow function:
- •WBC >3.500/mm3
- •neutrophil >1.500/mm3
- •platelets >150.000/mm3
- •hemoglobin >11 g%.
- •8) Adequate renal (creatinine <1.3 mg%), and hepatic function (bilirubin <1.5 mg% and transaminases <2 x n.v. If ALP > 2.5 x ULN, ALP LF and/or GGT = ULN).
- •9)Adequate cardiac function (FE >50%).
- •10)Signed informed consent.
- •11)Complete compliance of the participating center with the protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1)Pregnancy or lactation.
- •2)Distant metastasis.
- •3)Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent.
- •4)Sarcoma histotypes other than those mentioned in the inclusion criteria.
- •5) Prior CT and/or RT.
- •6)Serious psychiatric disease that precludes informed consent or limits compliance.
- •7)Medical disease limiting survival to less than two years, limiting compliance or which in the physician’s opinion might interfere significantly with the toxicity of the treatments.
- •8)Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (22).
- •9) Uncontrolled bacterial, viral or fungal infection.
- •10)Impossibility of ensuring adequate follow-up.
- •11)Failure to comply with the requirements of the present protocol leading to exclusion of the participating center.
研究者
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