EUCTR2015-001801-15-ES进行中（未招募）不适用
Multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- FIBICO
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
- •1) Male and female patients between the ages of 18 and 75 years;
- •2) Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual;
- •3) Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable;
- •4) Metastatic extent: M0;
- •5) Karnofsky index >70 o rPerformance status ?2;
- •6) Informed consent properly completed.
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1) Presence of metastatasis (M1);
- •2) Presence of unresectability criteria;
- •3) Urgent intervention for obstruction or perforation;
- •4) Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
- •5) Coexistence with another malignant neoplastic disease;
- •6) Severely altered liver, kidney and cardiovascular function;
- •7) Intolerance to treatment;
- •8) Administration of chemotherapy before the trial (use of neoadyuvance is discarded);
- •9) Pregnant or breastfeeding women.
研究者
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