EUCTR2011-004188-65-SE进行中（未招募）1 期
Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 7.6 - Nordic 8
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Histology and stagesHistologically proven adenocarcinoma in the colon or rectum
- •- At least 1 measurable metastatic disease manifestation according to the RECIST criteria (version 1.1)
- •- Potentially completely resectable or potentially curable metastatic colorectal cancer as determined by the local MDT conference and that requires tumour shrinkage before resection is possible. The following definitions are indicative:
- •-- 4 or more liver metastases (CRLeM) without extra-hepatic disease
- •-- 2 or more lung metastases (CRLuM) without hepatic or extra-hepatic disease
- •-- 1 or more CRLeM determined as potentially resectable (such as because of location) by the local MDT.
- •-- 1 or more CRLuM determined by the local MDT as potentially resectable (such as because of location).
- •-- Non-resectable primary disease with resectable CRLeM or CRLuM.
- •KRAS and BRAF status
- •- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF
- •General conditions
- •- age > 18 years
- •- WHO performance status = 1;
- •- expected survival > 3 months
- •- sufficient bone-marrow function (Hb = 6.2 µmol/l/Hb > 10 g/dl ANC = 1.5 x 109/l, thrombocytes = 100 x 109/l)
- •- sufficient kidney and liver function: total bilirubin = 1.5 x upper normal limit, serum creatinine = 1.25 x upper normal limit, ALAT = 3 x upper normal limit and = 5 x upper normal limit with liver metastases
- •- the patient must have signed an informed declaration of consent before being registered; this must be documentable according to national guidelines
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment
- •- previous chemotherapy for advanced/metastatic disease
- •- adjuvant chemotherapy unless completed more than 6 months before registration
- •- previous treatment with oxaliplatin or irinotecan
- •- previous treatment with cetuximab or other treatment for EGFR
- •- History of Inflammatory Bowel disease
- •- Severe or uncontrolled cardiovascular disease, congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
- •- Any condition that, according to the treating physician's judgement, could prevent the planned medical/surgical treatment from being carried out responsibly (such as uncontrolled active infection, known hypersensitivity or contra-indication for the planned treatment.
- •- Pregnant or breast-feeding women
- •- Patients of fertile age who do not want to use reliable contraception
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