Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Does response at Cystoscopy correlate with results of sample analysis
研究概览
简要总结
The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma.
- •suitable for treatment with radical concurrent chemoradiotherapy with GemX.
- •Standard radiological assessments with CT or MR for staging.
- •ECOG performance status 0-2
- •Adequate pre-treatment haematological and biochemical parameters
- •Age greater than or equal to 18 years
- •No significant co-morbidity thereby excluding patient from having radical treatment.
- •No previous treatment for diagnosis of muscle-invasive bladder cancer or other pelvic radiotherapy.
- •Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy
- •Patients must have given written informed consent
排除标准
- •Patients with a known history of anaphylactic reaction to any other drug.
- •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
- •Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial.
- •Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial Any other serious uncontrolled medical conditions
- •Clinical evidence of metastatic disease to brain
- •Any pregnant or lactating woman
- •Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
结局指标
主要结局
Does response at Cystoscopy correlate with results of sample analysis
时间窗: 3 months following the end of GemX chemoradiation
To test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hrs post-infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy. Gemcitabine will be measured in plasma by HPLC-MS using a published validated method. We have developed an assay for intracellular gemcitabine triphosphate which should determine levels in PBMCs from 10 - 15 ml blood. Response at Cystoscopy is measured as either complete response, superficial disease or muscle-invasive disease.
次要结局
- cause-specific and overall survival rates(3 years)
- acute and late toxicities as assessed by RTOG and LENT SOM scales(3 years)