JPRN-jRCTs031180375招募中2 期
Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.
Seto Yasuyuki0 个研究点目标入组 110 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Histologically confirmed esophageal squamous cell
- •carcinoma, adenosquamous carcinoma, or basal cell
- •2. Clinical stage II or III (excluding T4) according to the
- •7th UICC-TNM classification
- •3. Age over 20 years old.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •5. With or without evaluable lesions according to RECIST
- •6. No prior treatment for esophageal cancer, except for
- •(i) The depths of invasion are diagnosed as tumor
- •invades lamina propria mucosa(pT1a-LPM) after a
- •curative endoscopic mucosal resection (EMR) or
- •endoscopic submucosal dissection (ESD) for
- •esophageal cancer.
- •(ii) The depths of invasion are diagnosed as tumor
- •invades muscularis mucosa(pT1a-MM) and vascular
- •invasion negative after a previous curative EMR or
- •ESD for esophageal cancer.
- •7. No prior treatment of chemotherapy, radiotherapy or
- •endocrine therapy against any other malignant tumors,
- •except for hormone therapy for prostate cancer, which has
- •improved before 5 years.
- •8. Adequate organ functions
- •9. R0 esophagectomy is expected
- •10. Written informed consent
排除标准
- •1. Synchronous or metachronous (within 5 years) double
- •cancers, except for intoramucosal tumor curatively resected by local therapy
- •2. With active systemic infection disease
- •3. With active hepatitis B or C
- •4. With HIV infection
- •5. With a history of interstitial pneumonia, pulmonary
- •fibrosis or irradiation pneumonitis
- •6. Severe psychological illness.
- •7. With continuous systemic steroid or immune-suppressive
- •drug therapy.
- •8. Poorly controlled diabetes mellitus or thyroid diseases.
- •9. Unstable angina within 3 weeks or with a history of acute
- •myocardial infarction within 3months
- •10. With a history of hypersensitivity to docetaxel,
- •cisplatin or polysorbate 80-containing formulations
- •11. Pregnant and/or nursing women or men who wish to have
- •children in future
- •12. Judged to be unfit to participate in this study by
- •investigator
研究者
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