NCT00733616已完成2 期
Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status.
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •informed consent signed
- •Histological or cytological adenocarcinoma confirmation carcinoma on the esophago-gastric union or stomach (type I, II and III Siervent) metastatic or relapsed
- •measurable disease (following RECIST criteria)
- •older or equal 70 years old
- •Intermediate general status defined as at least one of the following characteristics: performance status (ECOG) = 2, weight loss ponderada between 10 and 25% in the last 3 months
- •life expectancy superior to 12 weeks
- •adequate hematological function: Neutrophils ≥1.50x109, platelets ≥100x109, Hemoglobin ≥10 g/dl
- •adequate liver function: Liver function (total bilirubine < 2 NV; GOT y GPT <3 NV (< 5 NV in case of liver metastasis; Alkaline phosphatase <3 NV ))
- •Adequate renal function: renal function (Creatinine clearance > 50mL/min), based on Cockroff - Gault. In case Creatinine clearance is < 50 ml/min, a test in urine will be done in 24 hours and if the value is > 50 ml/min, the patient could be eligible for the study
- •Potential fertile women negative pregnancy test in serum or urine, 10 days prior the first study dose given
- •Use an adequate contraceptive method (postmenopausal women should be amenorrheic at least 12 months previous the study to be considered as not potentially fertile (VN:upper limit on normal laboratory values)
排除标准
- •non measurable lesion as only disease evidence
- •previous chemotherapy treatment for advance disease. It wont´t be consider as exclusion criteria if chemo or radiotherapy has been given for localized disease and finished more than 1 year ago. In caso os only measurable disease in the radiated area, progressive disease has to be documented previous to the inclusion
- •functional dependency
- •hypersensitivity to Docetaxel, oxaliplatin or capecitabine
- •previous serious adverse events or unexpected to fluoropirimidin treatment and /or patients with proved deficit in dehidropirimidin deshidrogenase (DPD)
- •patients classified as "weak or fragile"
- •dependency on one or more of the daily activities following the daily activity scale from Katz
- •three or more comorbitities of the following: congestive cardiac insufficiency, cardiac valvulopathy, coronaripathia, chronic pulmonary disease (obstructive or restrictive), cerebrovascular disease, diabetes, concomitant neoplasms, collagen vascular disease, chronic hetopathy and incapacitate arthritis
- •presence of geriatric syndromes: moderate-severe dementia, stress delirium (urinary respiratory infection); moderate-severe depression that interfere in the habitual daily life; frequent falls (3 or more monthly); be disattended; urinary incontinence, without stress, infection, diuretics or prostatic hyperplasia; fecal incontinence without diarrhea or laxative; osteoporotic fracture of long bone or vertebral squash
- •Cardiac concomitant present:
- •Symptomatic auriculoventricular arrhythmia history, and /or
- •Congestive cardiac insufficiency non controlled by drugs, and / or
- •Myocardial infarct 12 months previous the inclusion, and /or
- •Symptomatic ischemic cardiopathy
- •active infectious process ((leukocytes superior to 12 x 109/l or fever upper to 38º, it is required thorax X:ray, hemoculture and urine culture 5 days previous to the inclusion)
- •severe or bad controlled concomitant disease
- •neoplastic history (except skin basocellular or in-situ cervical carcinoma properly treated) in the last 5 years
- •patients with any other medical or surgical important problem that, in the investigator opinion, could not allow to follow the treatment
- •not able to fulfill the protocol and follow-up
- •being involve in any investigational trial with any drug within 4 weeks prior the study treatment
结局指标
主要结局
objective response rate
时间窗: 2008-2011
次要结局
- adverse events(2008-2011)
- Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity(2008-2011)
研究者
研究点 (1)
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