NCT03790553招募中3 期
A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 646
- 试验地点
- 3
- 主要终点
- Overall survival in PET/CT non-responders
研究概览
简要总结
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joined the study voluntarily and signed informed consent form;
- •Age 18-75 years; both genders
- •Esophageal squamous cell carcinoma confirmed by pathology.
- •No radiotherapy, chemotherapy or other treatments prior to enrollment
- •Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
- •Use of an effective contraceptive for adults to prevent pregnancy.
- •No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
- •WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥ 100*109/L, ALAT and ASAT < 2·5 * ULN, TBIL < 1·5 * ULN, and Creatinine < 1·5 *ULN.
- •Life expectancy of more than 3 months.
- •Agreement of PET/CT accessment at 25-28 radiotherapy fraction.
排除标准
- •Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
- •Esophageal perforation, or hematemesis.
- •History of radiotherapy or chemotherapy for esophageal cancer.
- •History of surgery within 28 days before Day
- •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 who refused to use contraceptives.
- •Drug addiction, alcoholism or AIDS.
- •Uncontrolled seizures or psychiatric disorders.
- •Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.
研究组 & 干预措施
50.4Gy
Active Comparator
Total radiotherapy dose of 50.4Gy.
干预措施: Radiotherapy (Radiation)
61.2Gy
Experimental
Total radiotherapy dose of 61.2Gy.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall survival in PET/CT non-responders
时间窗: 2 years
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.
Overall survival in ITT population
时间窗: 2 years
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
- Progression-free survival(2 years)
- Questionnaire EORTC-QLQ-OES18(2 years)
- Questionnaire EORTC-QLQ-C30(2 years)
- Local control rate(2 years)
- Overall survival in PET/CT responders(2 years)
研究者
Kuai Le Zhao, MD
Professor
Fudan University
研究点 (3)
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