JPRN-jRCTs031180376招募中1 期
Phase I/II study of bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS) as first-line therapy for advanced esophageal cancer.
Seto Yasuyuki0 个研究点目标入组 38 人开始时间: 2019年3月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
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)Primary tumor located cervical esophagus (Ce) or thoracic esophagus (Te) according to the 7th UICC-TNM classification
- •2)Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma
- •3)Unresectable advanced or recurrent tumor with no indication for definitive treatment (surgery, radiotherapy, and chemoradiotherapy)
- •4)Age over 20 years old.
- •5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •6)Without symptomatic bone or brain metastases
- •7)Without massive pleural effusion (more than half of one side thoracic cavity) nor massive ascites (more than from pelvic cavity to upper abdomen)
- •8)With evaluable lesions according to RECIST ver 1.1 (measurable lesions not required)
- •9)As for previous therapy for esophageal cancer,either A) or B) must be fulfilled:
- •A) When preoperative chemotherapy or postoperative chemotherapy was given as previous therapy, meet all of the following 3 factors:
- •a. Recurrence was detected more than 12 weeks after previous therapy was completed.
- •b. Previous therapy was not terminated due to adverse events, patient refusal. Tumor response by previous therapy was not judged as disease progression.
- •c. Total dose of prior CDDP =<210 mg/m2.
- •10)Adequate organ functions as following:
- •Absolute neutrophil count >=1,500/mm3
- •Platelet count >=100,000/mm3
- •Hemoglobin level >=9.0g/dL
- •Total bililubin =<1.5mg/dL
- •Aspartate aminotrasferase (AST) =<100IU/L (in the case or liver metastases, =<200IU/L) .
- •Alanine aminotransferase (ALT) =<100IU/L (in the case or liver metastases, =<200IU/L) .
- •Serum creatinine =<1.5mg/dL
- •eGFR >=60ml/min/1.73m2 (Phase I), eGFR >=30ml/min/1.73m2 (Phase II)
- •11)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 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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