EUCTR2020-002300-40-IT进行中(未招募)1 期
/A - LARA 4
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 103 人开始时间: 2020年11月6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
- 103
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
- Female
入选标准
- •Age =18, ECOG 0-2, histological diagnosis of cervical cancer, stage FIGO IB2- IVA (stage 2009) + positive pelvic and/or aortic lymph nodes, absence of oncological pretreatment, informed consent, sufficient medullary, renal and hepatic function
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Age <18, ECOG >3, contraindications to radiotherapy (genetic hyper-radiosensitivity syndromes), contraindications to pelvic radiotherapy: ulcerative rectocolitis, acute diverticulitis, severe diverticulosis, chronic pelvic phgosis, previous pelvic radiotherapy, patient enrolled in another experimental study, presence of internistic pathologies that contraindicate the neoadjuvant chemotherapy treatment, radiochemotherapy or surgery (severe liver disease, cardiopathy, kidney failure, etc.), presence of other neoplasm, any significant medical condition which in the opinion of the investigator may interfere with the optimal participation of the patient in the study, use of antibiotics for at least 4 weeks prior to sample collection,alcoholic patient, diseases that affect gastrointestinal motility such as scleroderma, insulin-dependent diabetes and /or uncontrolled diabetes (Hgb-A1c> 8%), clinically significant dehydration, clinically detectable ascites, sepsis.
研究者
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