Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22)
研究概览
简要总结
To determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine. Secondary endpoints are time to progression, overall response rate and overall survival.
Study treatment will continue until disease progression or unacceptable toxicity.
详细描述
GAST-TaxXel is an open, phase II, single arm, non-randomized, Finnish multicenter trial. At least 50 subjects will be enrolled.
Primary endpoint:
To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22) in patients with gastric cancer who receive combination treatment with Taxotere and Xeloda.
Secondary endpoint:
To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS).
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
- 未提供
排除标准
- •Pregnant or lactating women (or potentially fertile women not using adequate contraception)
- •Presence of CNS metastases
- •Unresolved bowel obstruction or subobstruction
- •Chronic diarrhea
- •Clinically significant malabsorption syndrome
- •Inability to swallow tablets
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within previous 6 months, congestive heart failure
- •History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- •History of prior serious allergic reactions such as anaphylactic shock.
- •Peripheral neuropathy ≥ grade 2, unless related to mechanical etiology
- •Concurrent use of corticosteroids unless chronic treatment (i.e. initiated > 6 months prior to study entry) at low doses (≥ 20 mg methylprednisolone or equivalent)
- •History of allergy to drugs containing the excipient TWEEN 80® and/ or 5- fluorouracil.
- •Lack of physical integrity of the upper gastrointestinal tract.
- •Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy.
- •Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- •Patients who cannot be regularly followed up for psychological, social, family or geographic reasons.
结局指标
主要结局
To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22)
时间窗: at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress
次要结局
- To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS).(every 3 cycles, at the end of study and every 3 month)