JPRN-jRCTs031180110已完成3 期
JCOG0909: A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma - EC-CRT+Salvage-sP3
KITAGAWA Yuko0 个研究点目标入组 96 人开始时间: 2019年2月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
This combined modality treatment of definitive CRT with salvage treatment showed acceptable toxicities, favorable 5-year survival, and promising esophageal preservation rate for cStage II/III esophageal cancer for the patients hoping esophageal preservation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma by endoscopic biopsy from esophageal primary tumor
- •2) All lesions located (primary tumor, esophageal intramural metastases, and intraepithelial spread) in the thoracic esophagus (the 6th edition of the UICC TNM classification)
- •3) Clinical stage II or III without T4
- •4) Aged 20 to 75 years old
- •5) ECOG Performance status 0 or 1
- •6) No previous therapy against esophageal cancer except for the following cases
- •(i) Complete resection by EMR/ESD (diagnosed as pT1a-EP (M1) or pT1a-LPM (M2) tumors)
- •(ii) Complete resection by EMR/ESD (diagnosed as pT1a-MM (M3) tumor without lymphovascular invasion)
- •7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval
- •8) Adequate organ functions
- •9) Patients do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy, but agree to receive a salvage treatment including surgery when the disease is residual or recurrent
- •10) Written informed consent
排除标准
- •1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
- •2) Active infection requiring systemic therapy
- •3) Fever over 38 degrees Celsius
- •4) Pregnant or lactating women or women of childbearing potential
- •5) Psychiatric disease or symptom
- •6) Patients requiring systemic steroids medication (internal or intravenous use)
- •7) Serum HBs antigen positive (the data within 1 year before the registration)
- •8) Uncontrollable diabetes mellitus with HbA1c of 7.0% or higher
- •9) Uncontrollable hypertension
- •10) Unstable angina (onset or worse heart attack of angina within 3 weeks,) or with a history of myocardial infarction within 6 months.
- •11) Interstitial pneumonia, fibroid lung, or severe emphysema
- •12) With a history of cerebrovascular disorder (brain infarction, intracerebral bleeding, or transient cerebral ischemia attack) within 6 months
- •13) Drug allergy for iodic drug
研究者
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