NCT00162721Unknown3 期
Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas
研究概览
简要总结
This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed uterine sarcoma (rereading in reference centers)
- •Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
- •All stages <= stage III (FIGO modified for endometrial carcinoma)
- •Full surgical exeresis
- •Age >= 18 years and physiological age <= 65 years
- •Negative extension check-up (thoracic and abdomino-pelvic TDM)
- •Performance status (PS) <= 2 (ECOG)
- •Normal haematologic functions (absolute neutrophil count > 1,500/mm3, platelets > 100,000/mm3)
- •Serum creatinine < 1.25 x ULN
- •Good hepatic check-up (total serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN)
- •Absence of neuropathy > grade 1
- •Left ventricular ejection fraction > 50% (by isotopic or ultrasound scan determination)
- •Written informed consent
排除标准
- •Low grade endometrial stromal sarcoma
- •Time since surgery > 8 weeks
- •Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
- •Antecedents or evolutive psychiatric disorder
- •Concurrent active infection or other serious uncontrolled systemic disease
- •Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix
结局指标
主要结局
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas
次要结局
- Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
- Evaluation of global toxicity of the treatment in each arm
研究者
研究点 (2)
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