JPRN-jRCTs031180143进行中（未招募）3 期
JCOG1314: A randomized controlled phase III study comparing docetaxel, CDDP and 5-FU with CDDP and 5-FU in patients with metastatic or recurrent esophageal cancer - MIRACLE study
TSUBOSA Yasuhiro0 个研究点目标入组 240 人开始时间: 2019年2月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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 <= 75age old（—）
- 性别
- All
入选标准
- •1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction (the UICC 7th edition)
- •2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma (Only Siewert type I is eligible in case of adenosquamous carcinoma or adenocarcinoma.)
- •3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy
- •A)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled:
- •i)Having metastatic lesion except for #102 or #104 metastases
- •ii)cT1-cT4a
- •iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through
- •B)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled:
- •i)Having metastatic lesion except for #102 or #104 metastases
- •ii)Dysphagia score =<2
- •4)Aged 20 to 75 years old
- •5)ECOG PS of 0 or 1
- •6)No symptomatic bone or brain metastases
- •7)No massive ascites/pleural effusion
- •8)Measurable lesions not required
- •9)As for previous therapy,the following regimens are eligible. And, either A) or B) must be fulfilled.
- •A)When preoperative chemotherapy (CF, CS, or DCF regimen) or postoperative chemotherapy (CF, or S-1 regimen) was given as previous therapy, meet all of the following 4 factors:
- •i)Recurrence was detected more than 24 weeks after previous therapy was completed
- •ii)Previous therapy was not terminated due to adverse events, patient refusal, andtumor response by previous therapy was not judged as disease progression
- •iii)Total dose of prior CDDP =< 210 mg/m2
- •iv)Total dose of prior DOC =< 210 mg/m2
- •B)When preoperative chemoradiotherapy (CF-RT), concurrent chemoradiotherapy (CF-RT, CS-RT, or DCF-RT) or radiotherapy alone were received as previous therapy, meet all of the following 5 factors:
- •i)More than 52 weeks after radiotherapy when lung was involved in radiation field
- •ii)No history of grade 2-4 pneumonitis
- •iii)Previous therapy was not terminated due to adverse events, patient refusal, andtumor response by previous therapy was not judged as disease progression
- •iv)Total dose of prior CDDP =< 210 mg/m2
- •v)Total dose of prior DOC =< 210 mg/m2
- •10)Sufficient organ function
- •11)Written informed consent
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
- •2) Active infection requiring systemic therapy.
- •3) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding.
- •4) Psychological disorder difficult to participate in this clinical study .
- •5) Patients requiring systemic steroid medication.
- •6) Under treatment with flucytosine, phenytoin, or warfarin.
- •7) History of hypersensitivity to DOC, CDDP, or polysorbate 80.
- •8) Poorly controlled diabetes mellitus.
- •9) Severe pulmonary fibrosis or emphysema.
- •10) Poorly controlled hypertension.
- •11) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
- •12) Positive HBs antigen, or positive HIV antibody
研究者
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