EUCTR2015-002701-11-NO进行中（未招募）1 期
ADJUVANT CHEMOTHERAPY IN ELDERLY – GERIATRIC ASSESSMENT AND PROGNOSTIC GENE SIGNATURES - ACE
Oslo University Hospital0 个研究点开始时间: 2015年8月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •·Radical surgery (R0/R1) for colon cancer
- •·Histologically verified adenocarcinoma of the colon
- •·Histologically verified lymph node metastases (Stage III)
- •·Age = 75 years
- •·Able to undergo ambulatory treatment (adequate physical and mental function)
- •·Lab values as the following:
- •- absolute neutrophil count ³1.5 x 109/L
- •- platelet count ³100 x 109/L
- •- clinically acceptable haemoglobin levels
- •- creatinine levels indicating renal clearance of ³30 ml/min
- •- bilirubin =1.5 x UNL (upper normal limit)
- •·Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP and national regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •·Distant metastases (stage IV)
- •·Frail according to geriatric assessment
- •·Significant cardiovascular disease (congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia) or myocardial infarction within the past 12 months
- •·Previous treatment with chemotherapy for colorectal cancer
- •·Metastatic disease from other cancer
- •·Reduced cognitive function not enabling ability to give informed consent or compliance with the study
- •·History of prior or concurrent malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix
- •·Adverse reactions to capecitabine or related drugs. Need to use medications contraindicated according to SmPC of the IMP(s), such as sorivudin, brivudin or chemically related compounds. Any other contraindication listed on the SmPC of the IMP(s)
- •·Use of methotrexate or other cytotoxic drugs as treatment of rheumatoid arthritis or other inflammatory disease and where it is considered contraindicated to stop this medication
- •·Known DPD deficiency
- •·Any reason why, in the opinion of the investigator, the patient should not participate
研究者
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