A Phase II/III Study Comparing Simultaneous Integrated Boost (SIB) Intensity Modulated Radiation Therapy (IMRT) With S1 Based SIB-IMRT Followed by Adjuvant Chemotherapy With S1 in Elderly Patients With Esophageal or Esophagogastric Cancer (3JECROG-P01)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Ratiotherapy alone is the current standard treatment for elderly esophageal or esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly patients. This study aimed to assess the efficiency and safety of simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric cancer patients
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥70 years
- •Esophageal or Esophagogastric cancer
- •Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
- •Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
- •No distant metastasis other than supraclavicular lymph nodes
- •No prior history of thoracic radiation
- •Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
- •Informed consent
排除标准
- •Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- •With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
- •History of allergic reactions attributed to similar chemical or biologic complex to S-1
- •With esophageal fistula, perforation, cachexia prior to treatment
- •Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- •History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- •Pregnant or lactating females
研究组 & 干预措施
SIB-IMRT
SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).
干预措施: SIB-IMRT (Radiation)
S1 based SIB-IMRT
S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.
干预措施: SIB-IMRT (Radiation)
S1 based SIB-IMRT
S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.
干预措施: S-1 (Drug)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
- Radiotherapy toxicities(2 months)
- Remission rate of dysphagia(Change from baseline to 1 month after treatment)
- Chemoradiotherapy toxicities(2 months)
- Comprehensive geriatric assessment(Baseline)
- Progression free survival(1 year)
- Time of locoregional control and failure site within or outside radiation field(1 year)
研究者
Zefen Xiao
Dr.
Chinese Academy of Medical Sciences