ISRCTN17282276已完成未知
A multicentre phase II trial to assess the efficacy of epirubicin, cisplatin and capecitabine in carcinomas of unknown primary origin (CUP): incorporating the prospective validation of molecular classifiers in diagnosis and classification and exploratory metabonomics
HS Greater Glasgow and Clyde (UK)0 个研究点目标入组 59 人开始时间: 2011年2月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •Translational Registration (part 1):
- •1. Uncertain or unknown primary site of origin of malignancy. This includes patients with a suspected primary site (on history, histology or radiology) but as yet unconfirmed.
- •2. Histologically confirmed carcinomas (adenocarcinomas, squamous cell carcinoma [SCC] and undifferentiated are all acceptable) from tru-cut biopsy and/or operative procedure
- •3. 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 Trial Management Group (TMG)
- •4. Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations, can only be offered the translational part of the study if either a subsequent tru-cut biopsy, or an operative procedure is to be performed at some stage of the patients investigations or surgical treatment (such as debulking or bypass surgery)
- •5. Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations, can however still be offered the clinical part of the study
- •6. Written informed consent is required for both parts separately
- •Clinical Trial Registration for ECX treatment (part 2):
- •1. Histologically or cytologically confirmed carcinomas, in which a primary cannot be conclusively identified following appropriate investigations and discussion in the appropriate MDM:
- •1.1. 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
- •1.2. Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations, 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.
- •1.3. 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. Aged less than 18 years
- •4. Performance status less than 2
- •5. Life expectancy greater than 12 weeks
- •6. Adequate haematological function: absolute neutrophil count less than 2.0 x 10^9/l, white cell count less than 3.0 x 10^9/l, platelets less than 100 x 10^9/l
- •7. Adequate calculated or measured renal function: serum creatinine less than 120 mg/dl and creatinine clearance greater than 60 ml/min (renal function assessed by either 24 hour creatinine or EDTA clearance, is often more accurate than calculated clearances which can underestimate the true clearance)
- •8. Adequate hepatic function: bilirubin within 2 x normal range, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 5 times the upper limit of normal
- •9. Written informed consent
排除标准
- •Translational Registration (part 1):
- •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)
- •Clinical Trial Registration for ECX treatment (part 2):
- •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 electrocardiogram (ECG) or cardiac history having a left ventricular ejection fraction (LVEF) of lower limit of normal range for institution as determined by multiple gated acquisition (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.
- •9. Hearing difficulties which in the investigators opinion, might significantly worsen with cisplatin therapy
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