JPRN-UMIN000017552已完成2 期
A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy - A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy
Kyushu Study group of Clinical Cancer0 个研究点目标入组 40 人开始时间: 2015年5月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
pdated survival analysis of a phase II study of SOX plus trastuzumab for HER2 positive advanced gastric cancer:(KSCC1501B) Tetsuya Kusumoto, Tomomi Kashiwada, Katsunori Shinozaki, Satoshi Yuki, Masaaki Iwatsuki, Hironaga Satake, Shoji Tokunaga, Yasunori Emi, Akitaka Makiyama, Hiroshi Saeki, Eiji Oki, Hideo Baba, Yoshihiko Maehara; Kyushu Study Group of Clinical Cancer (KSCC)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment 2)The patient has severe drug hypersensitivity (particularly to platinum analogs,5-FU,S-1,or trastuzumab) 3)The patient has peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 4)The patient has an active infection 5)The patient has poorly controlled hypertension 6)The patient has poorly controlled diabetes 7)If a 12-lead ECG reveals marked ECG abnormalities up to 14 days prior to enrollment or the patient has heart disease that may pose a problem 8)The patient has severe pulmonary disease 9)he patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction 10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions 11)The patient is receiving phenytoin, warfarin potassium,or flucytosine 12)The patient has moderate or more severe fluid accumulation in body cavities,such as pleural effusions and ascites,that continually requires treatment such as drainage 13)The patient has brain metastasis or clinical features suggesting brain metastasis 14)The patient has extensive bone metastasis (as determined by the patient's primary physician) 15)The patient has watery diarrhea (watery stool)(Grade 2 or worse) 16)The patient has active multiple cancers 17)The patient has a history of receiving platinum-based antineoplastic agents (e.g. oxaliplatin and cisplatin) 18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner 19)The patient tests positive for HBsAg or antibodies to HCV (Date of testing required) 20)A patient who is deemed to need antiviral therapyb (as of enrollment) for HBV-related hepatitis 21)A lead investigator or the patient's primary physician otherwise deems that participation in this trial is not appropriate for the patient
研究者
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