A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Objective Response Rates
研究概览
简要总结
This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer
详细描述
There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity.
Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced or metastatic gastric cancer.
- •Measurable or evaluable disease.
- •Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
- •Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
- •Karnofsky performance status > 70%.
- •Age ≥18 years.
- •Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function.
- •Patients must be able to understand the nature of this study and give written informed consent.
排除标准
- •Active infection
- •History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
- •Patients with CNS metastases
- •Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.
- •Malnutrition or loss of > 10% of body weight during the last month.
- •Peripheral neuropathy ≥ grade 2
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- •Psychiatric illness or social situation that would preclude study compliance.
- •Pregnant or lactating women.
研究组 & 干预措施
2
FLOX
干预措施: Oxaliplatin (Drug)
1
IOX
干预措施: Irinotecan (Drug)
1
IOX
干预措施: Oxaliplatin (Drug)
2
FLOX
干预措施: Fluorouracil (Drug)
2
FLOX
干预措施: Leucovorin (Drug)
结局指标
主要结局
Objective Response Rates
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
次要结局
- Overall survival(1 year)
- Time to progression(1 year)
- Quality of life(Assessment every two cycles)
- Symptoms improvement(Assessment every two cycles)
- Toxicity(Toxicity assessment on each chemotherapy cycle)