NCT04328948招募中3 期
A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer
National Cancer Center, Japan1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Major progression-free survival
研究概览
简要总结
This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
- •All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
- •Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
- •The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM
- •Aged 20 years and older.
- •ECOG Performance status 0 or
- •No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration.
- •No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.
- •Major organ function is preserved. 1) WBC<=12,000/mm3 2) ANC>=1,500/mm3 3) Hb>=10.0 g /dL 4) PLT>=10,000/mm3 5) T-bil<=1.5 mg /dL 6) AST<=100 IU/L 7) ALT<=100 IU/L 8) SpO2>=95% 9) Ccr>=60 mL/min
- •Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
- •Written informed consent is obtained.
排除标准
- •Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.
- •Active infection requiring systemic therapy.
- •Fever over 38 degrees Celsius
- •Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.
- •Psychological disorder, which is difficult to participate in this clinical study.
- •Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •Positive for HBs antigen or HIV antigen.
- •Diabetes mellitus, which is uncontrollable with continuous use of insulin or hypoglycemic agents.
- •Uncontrolled arterial hypertension.
- •History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
- •Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
- •Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
- •With a history of cerebrovascular disorder within 6 months.
- •Drug allergy for iodic drugs.
结局指标
主要结局
Major progression-free survival
时间窗: The primary analysis will be held 5-years after the last patient was enrolled.
If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events.
次要结局
- Overall survival(The primary analysis will be held 5-years after the last patient was enrolled.)
- Esophagectomy-free survival(The primary analysis will be held 5-years after the last patient was enrolled.)
- Long term toxicity(The primary analysis will be held 5-years after the last patient was enrolled.)
- Complete response rate(The primary analysis will be held 5-years after the last patient was enrolled.)
- Progression-free survival(The primary analysis will be held 5-years after the last patient was enrolled.)
- Adverse events(The primary analysis will be held 5-years after the last patient was enrolled.)
研究者
Ken Kato
National Cancer Center Hospital
National Cancer Center, Japan
研究点 (1)
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