Unique ID issued by UMIN | UMIN000005366 |
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Receipt number | R000006291 |
Scientific Title | A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. |
Date of disclosure of the study information | 2011/04/26 |
Last modified on | 2018/01/04 09:50:45 |
A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
A phase II study of trastuzumab added to docetaxel and S-1 for HER2-positive advanced gastric cancer.
A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
A phase II study of trastuzumab added to docetaxel and S-1 for HER2-positive advanced gastric cancer.
Japan |
gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and tolerability of trasuzumab added to S-1+docetaxel in HER2-positive advanced gastric cancer patients.
Safety,Efficacy
Phase II
progression free survival
safety, objective response rate, overall survival, time to treatment failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous infusion of trastuzumab (loading dose 8 mg/kg, 6 mg/kg) on day1, Intravenous administration of 40 mg/m2 docetaxel on Day 1, and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Pathological proven adenocarcinoma of inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach
2) HER2-positive tumors
3) Age 20-79 years
4) Measurable disease or non-measurable but assessable disease
5) No prior chemotherapy except for adjuvant chemotherapy with S-1
6) Adequate organ function
7) ECOG performance status<=2
8) Ejection fraction more than 50% by
ultrasound or MUGA
9) Expected more than 3 months survival
10) Sufficient oral intake
11) With written informed consent
1) with severe allergy to Trastuzumab, S-1 and docetaxel
2) Active infection or other inflammatory disease
3) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
4) Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, uncontrollable diabetes millutus, hypertension, and respiratory insufficiency.
5) History of cardiac disease
6) Dyspnea at rest, due to complications of advanced malignancy or other cardiovascular disease
7) Metastasis to CNS
8) Grade 3-4 peripheral sensory neuropathy
9) pregnant or nursing patient or with intent to bear baby
10) Inappropriate for the trial at the physician's assessment
40
1st name | |
Middle name | |
Last name | Toshiyoshi Fujiwara |
Okayama University Graduate school of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Gastroenterological Surgery
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
+81-86-235-7257
toshi_f@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Shunsuke Kagawa |
Okayama University Hospital
Department of Gastroenterological Surgery
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
+81-86-235-7257
skagawa@md.okayama-u.ac.jp
Okayama University
Okayama University
Other
NO
2011 | Year | 04 | Month | 26 | Day |
Published
https://link.springer.com/article/10.1007/s00280-017-3505-4?wt_mc=Internal.Event.1.SEM.ArticleAuthor
Completed
2011 | Year | 03 | Month | 25 | Day |
2011 | Year | 04 | Month | 01 | Day |
2017 | Year | 10 | Month | 01 | Day |
2017 | Year | 12 | Month | 26 | Day |
2011 | Year | 04 | Month | 01 | Day |
2018 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006291
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