EUCTR2018-004231-72-ES进行中（未招募）1 期
Randomized study of the detection of RAS / BRAF mutations by BEAMing technology in advance of the radiological diagnosis of progression in patients with metastatic colorectal cancer RAS / BRAF WT and primary tumor in the left colon / rectum
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)0 个研究点目标入组 80 人开始时间: 2019年6月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
入选标准
- •? Patients older than or equal to 18 years old.
- •? Informed consent.
- •? Karnofsky index =70% at the time of inclusion of the trial.
- •? Patients with unresectable CCRm.
- •? Location of the primary tumor in the left colon or rectum.
- •? Genotype RAS / BRAF WT by OncoBEAM ™ before starting the 1st line treatment.
- •? There is no contraindication or QT in Oxaliplatin / Irinotecan and anti-EGFR
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? History of a primary cancer other than CRC in the last five years (with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix).
- •? Any type of previous treatment for your metastatic disease.
- •? Patients with resectable disease and / or who receive surgical treatment of the tumors.
- •? Analytical alterations that avoid inclusion in Clinical Trial
- •o Hemoglobin <9 g / dL
- •o Platelets <100x109 / L
- •or Neutrophils <1.5x109L
- •o Total bilirubin ?1.5 x ULN
- •or ALAT and ASAT ?2.5 x ULN (?5x ULN in case of liver metastases)
- •o Creatinine ?1.5 x ULN
- •or Pregnancy
研究者
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