NCT01605305已完成2 期
Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- TPP
研究概览
简要总结
The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.
详细描述
Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus
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
- Single (Investigator)
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 proven primary thoracic esophageal squamous cell carcinoma
- •Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
- •Presence of at least one index lesion measurable by CT scan or MRI
- •18~75 years
- •Life expectancy of ≥ 3 months
- •ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
- •Cr ≤ 1.0×UNL
- •TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL
- •Signed written informed consent
排除标准
- •Previous exposure to oxa therapy in one year
- •diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
- •chronic diarrhea,enteritis,intestine obstruction which are not under control
- •Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
- •peripheral neuropathy ≥ CTCAE 1
- •Other serious disease
- •Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
- •USE OTHER ANTITUMOR THERAPY
- •Breast-feeding or pregnant women, no effective contraception if risk of conception exists
研究组 & 干预措施
FOLFOX6
Experimental
干预措施: FOLFOX6 (Drug)
结局指标
主要结局
TPP
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
- OS(from the first cycle of treatment (day one) to two month after the last cycle)
研究者
Chang Jian Hua
associate chief physician
Fudan University
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