NCT03585530Unknown2 期
Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Phase-II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall survival(OS)
研究概览
简要总结
Concurrent chemoradiotherapy is one of the curative options for esophageal squamous cell carcinoma. We evaluated the efficacy and toxicity of raltitrexed with concurrent radiotherapy in elderly patients with esophageal cancer.
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
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologic diagnosis of esophageal carcinoma. ECOG performance status 0-
- •Age:70-85 years. Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy.
- •Stage IIa-Ⅳa(AJCC 2002). Target lesions can be measured according to RECIST criteria. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN.
排除标准
- •Multiple carcinomas of the esophagus. Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula.
- •Metastatic disease (M1b). A primary tumor that extended to within 2 cm of the gastroesophageal junction. Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor.
- •history of a second malignancy other than nonmelanoma skin cancer.
研究组 & 干预措施
treatment group
Experimental
干预措施: raltitrexed (Drug)
结局指标
主要结局
Overall survival(OS)
时间窗: 3 years
From the date of randomization until the date of death
次要结局
- Disease-free survival (DFS)(3 years)
- treatment-related toxicities(From the date of randomization until six months after treatment completion)
- Quality of life(QOL)(3 years)
研究者
研究点 (1)
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