Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- overall survival difference of definitive radiotherapy and chemoradiotherapy groups
研究概览
简要总结
So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
详细描述
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.
Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.
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
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicates no limit on eligibility based on the sex of participants
- •The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
- •Esophageal squamous cell carcinoma confirmed by pathology
- •No radiotherapy, chemotherapy or other treatments prior to enrollment
- •Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
- •Use of an effective contraceptive for adults to prevent pregnancy
- •No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
- •No immunodeficiency
- •Life expectancy of more than 3 months.
排除标准
- •Total radiotherapy dose cannot reach 61.2Gy/34Fx
- •Esophageal perforation, or hematemesis
- •History of radiotherapy or chemotherapy for esophageal cancer
- •History of surgery within 28 days before Day 1
- •History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
- •Participation in other interventional clinical trials within 30 days
- •Pregnant or breast-feeding women or fertile patients
- •Drug addiction,
- •alcoholism or AIDS
- •Uncontrolled seizures or psychiatric disorders
研究组 & 干预措施
radiotherapy
61.2Gy/34Fx
干预措施: radiotherapy (Radiation)
chemoradiotherapy
50.4Gy/28Fx; Paclitaxel plus carboplatin
干预措施: Paclitaxel plus carboplatin (Drug)
chemoradiotherapy
50.4Gy/28Fx; Paclitaxel plus carboplatin
干预措施: radiotherapy (Radiation)
结局指标
主要结局
overall survival difference of definitive radiotherapy and chemoradiotherapy groups
时间窗: 3-year
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
次要结局
- radiation side effects(acute side effects within 3 months, late side effects for 3 months later)
- cancer specific survival(3-year)
- difference of quality of life between different groups(the period of treatment within 7 weeks and follow up time with an average of 3months)