EUCTR2008-000657-35-GB进行中（未招募）1 期
A multi-centre phase II trial to assess the efficacy of epirubicin, cisplatin and capecitabine incorporating the prospective validation of molecular classifiers and exploratory metabonomics. - CUP ONE
Greater Glasgow and Clyde Health Board (GGCHB)/University of Glasgow0 个研究点目标入组 59 人开始时间: 2008年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
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
- •INCLUSION - TRANSLATIONAL PART
- •1. Uncertain or unknown primary site of origin of malignancy
- •2. Histologically confirmed carcinomas (adenocarcinomas, SCC & undifferentiated are all acceptable) from tru-cut biopsy and/ or operative procedure
- •- lymphomas, sarcomas, germ-cell tumours are not intended to be either part of this trial, if uncertain or equivocal they can be discussed with the TMG
- •- Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations (see below), can be offered the study only if either a subsequent tru-cut biopsy and/or operative procedure is to be performed at some stage of the patients investigations or surgical treatment (such as debulking or bypass surgery). Written informed consent is required for both parts separately.
- •INCLUSION - CLINICAL TRIAL
- •1. Histologically or cytologically confirmed carcinomas, in which a primary cannot be conclusively identified following appropriate investigations and discussion in the appropriate MDM (see 4.1 above).
- •- Lymphomas, sarcomas and germ-cell tumours are not intended to be part of this trial, if uncertain or equivocal they can be discussed with the TMG
- •- Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations (see 4.3 below), can be offered both parts of the study only if either a subsequent tru-cut biopsy and/or operative procedure is to be performed at some stage of the patient’s investigations or surgical treatment (such as debulking or bypass surgery). Written informed consent is required for both parts separately.
- •- If only cytological confirmation from a FNA is possible, only the second part of the study can be considered.
- •2. Inoperable metastatic carcinoma with at least unidimensional measurable disease.
- •3. Age > 18 years
- •4. Performance status < 2
- •5. Life expectancy >12 weeks
- •6. Adequate haematological function: absolute neutrophil count > 2.0 x 109/l, white cell count > 3.0 x 109/l, platelets > 100 x 109/l
- •7. Adequate renal function: serum creatinine < 120?m/l and creatinine clearance > 50 ml/min
- •8. Adequate hepatic function: bilirubin within 2x normal range, AST or ALT > 5 times the upper limit of normal
- •9. Written informed consent
- •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
- •EXCLUSION - TRANSLATIONAL
- •1. Significant intercurrent medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to give informed consent
- •2. Non-carcinoma histology (lymphomas, sarcomas and germ-cell tumours are not intended to be part of this trial; if equivocal discuss with TMG)
- •EXCLUSION - CLINICAL TRIAL
- •1. Previous chemotherapy
- •2. Co-existent second malignancy or history of prior malignancy within 5 years, except for adequately treated basal cell carcinoma and non-invasive carcinoma of the cervix. If history of prior malignancy within 10 years, the previous histology should be compared and available for central review.
- •3. Pregnant or lactating women. Women of child bearing potential not prepared to use effective contraception
- •4. Significant intercurrent medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to give informed consent or tolerate the therapy
- •5. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG or cardiac history having a LVEF of lower limit of normal range for institution as determined by MUGA scan or echocardiogram.
- •6. The presence of proven cerebral metastases
- •7. Any chemotherapy, hormonal or immunotherapy or other investigational drug within the preceding 4 weeks (steroids are permissible).
- •8. Previous radiotherapy is allowed but not to sites of assessable disease. No chemotherapy is to be given until resolution of all acute radiotherapy effects or a minimum of 6 weeks has elapsed since end of radiotherapy. Radiosensitisation with chemotherapy during radiotherapy is not allowed.
研究者
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