Phase I/II Dose Escalation by Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Overall survival (phase II)
研究概览
简要总结
Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histo-pathologically proven diagnosis of esophageal squamous cell carcinoma. Age ≥18 and ≤80 ECOG performance status 0-
- •Clinical diagnosis of ≤5 mediastinal lymph nodes recurrence after esophagectomy.
- •Patients without distant metastasis and life expectancy ≥ 3 months. adequate liver and renal function and adequate bone marrow reservation. Written, signed informed consent.
排除标准
- •Prior radiotherapy to recurrence site of esophageal cancer. Other co-existing malignancies or malignancies diagnosed within the last 5 years.
- •Pregnant women. Women who are breastfeeding a baby. Patients with uncontrolled serious medical or mental illnesses.
研究组 & 干预措施
treatment group
干预措施: treatment group(phase I) (Radiation)
treatment group
干预措施: treatment group (phase II) (Radiation)
结局指标
主要结局
Overall survival (phase II)
时间窗: up to 1 year
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)
时间窗: up to 3 months
DLT was defined as grade 4 or higher hematological toxicities and/or grade 3 or higher nonhematological toxicities.
次要结局
- Overall survival (phase I)(up to 1 year)
- late Toxicity (phase II)(up to 2 year)
- 1-year local progression-free survival(up to 1 year)
- Late toxicity (phase I)(up to 2 year)
- Overall survival (phase II)(up to 2 year)
- acute Toxicity (phase II)(up to 3 months)
研究者
Shengguang Zhao
associate chief physician
Ruijin Hospital