Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
Primary objective:
To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF])
Secondary objectives:
- To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
- To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
- •Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion.
- •Performance status Karnofsky index >70%
- •Life expectancy of more than 3 months
- •Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)
- •Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value
- •Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL
- •No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant therapy and first relapse.
- •At least 6 weeks from prior radiotherapy and 3 weeks from surgery
- •Complete initial work-up within two weeks prior to first infusion for clinical evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory.
排除标准
- •Pregnant or lactating women
- •Patients with reproductive potential not implementing adequate contraceptive measures
- •Other tumor type than adenocarcinoma
- •Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse within 12 months from the end of adjuvant
- •Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative dose > 300mg/m²
- •Previous or current malignancies other than gastric carcinoma, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
- •Patients with known brain or leptomeningeal metastases
- •Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria
- •Other serious illness or medical conditions:
- •unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •history of significant neurologic or psychiatric disorders including dementia or seizures
- •active uncontrolled infection
- •active disseminated intravascular coagulation
- •other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- •Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment at low doses
- •Definite contraindications for the use of corticosteroids
- •Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml
- •Liver impairment with AST or ALT more than 1.5UNL associated with alkaline phosphatase more than 2.5UNL
- •Concurrent or within 4 week period administration of any other experimental drugs
- •Concurrent treatment with any other anti-cancer therapy
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
干预措施: 5-fluorouracil (Drug)
1
Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
干预措施: Cisplatin (Drug)
1
Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
干预措施: Docetaxel (Drug)
2
Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
干预措施: 5-fluorouracil (Drug)
2
Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Time to progression
时间窗: Throughout the study period
次要结局
- Laboratory toxicities/symptomatology(Throughout the study period)
- Safety profile(Throughout the study period)
- Overall survival(From beginning to end of study)
- Tumor response(every 8 weeks)
- Clinical toxicities/symptomatology(Throughout the study period)