EUCTR2006-002389-21-GB进行中（未招募）1 期
A phase I/II study of Docetaxel (Taxotere, TM), Cisplatinum and Capecitabine (Xeloda, TM) (TCX) in patients with advanced oesophago-gastric cancer. - TCX
orth Wales NHS Trust0 个研究点目标入组 80 人开始时间: 2006年7月23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
- 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
- •1. Written informed consent to participate in the trial
- •2. Male or female 18 years or older
- •3. Histologically verified locally advanced (deemed unsuitable for radical treatment) or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction or stomach. Locally recurrent or metastatic disease following radical treatment is permitted.
- •4. Uni-dimensional measurable disease on MRI/CT in accordance with RECIST guidelines
- •5. No prior chemotherapy
- •6. Creatinine clearance of greater than or equal to 60 mls/minute.
- •7. Adequate hepatic function: Total bilirubin <1 UNL, AST (SGOT) and ALT (SGPT) < or = 2.5 UNL, Alkaline phosphates < or = 5 UNL
- •8. Adequate bone marrow function: WBC > 3 x 10^9/l, neutrophils > 1.5 x 10^9/l, platelets > 100 x 10^9/l
- •9. Previous radiotherapy is permitted where relapse is outside the radiotherapy fields
- •10. Patients should have a projected life expectancy of at least 3 months
- •11. WHO PS 0, 1 or 2
- •12. Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix
- •13. Previous chemotherapy with platins, taxanes or fluoropyrimidines is not permitted.
- •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
- •1. Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
- •2. Any serious uncontrolled medical conditions
- •3. Any pregnant or lactating woman. Any woman of childbearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment. Any man with a partner of child bearing potential must take adequate precautions to prevent pregnancy during treatment.
- •4. Any patient unable to complete the quality of life questionnaire
- •5. Subjects considered by the investigator to be at risk of transmitting any infection through blood or other body fluid including Aquired Immune Deficiency Syndrome (AIDS), or other sexually transmitted disease or hepatitis.
- •6. Patient participation in other studies
- •7. Planned radiotherapy in the area of disease which is being assessed for response.
研究者
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