Unique ID issued by UMIN | UMIN000010549 |
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Receipt number | R000012334 |
Scientific Title | Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma |
Date of disclosure of the study information | 2013/04/20 |
Last modified on | 2017/10/26 23:11:13 |
Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma
Second line treatment of Temozolomide in neuroendocrine carcinoma
Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma
Second line treatment of Temozolomide in neuroendocrine carcinoma
Japan |
Neuroendocrine carcinoma (Grade3)
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Pneumology | Endocrinology and Metabolism | Surgery in general |
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Endocrine surgery |
Breast surgery | Obstetrics and Gynecology | Adult |
Malignancy
NO
The pourpose of this study is to evaluate the efficacy of Temozolomide monotheraphy
Safety
overall response rate
overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients were treated temozolomide (150mg/m2) orally on day1 to 5 of 28-day cycle.
18 | years-old | <= |
76 | years-old | > |
Male and Female
pathological diagnosed neuroendocrine carcinoma Grade3
Any primary sites are included
The cases of refractory first-line treatment
ECOG PS 0-1
granulocyte count > 1500
platelet count > 10000
cerebral vascular disease
untreatment bone fracture
uncontrolable ulcer
tendency of bleeding
another major carcinoma
cerebral vascular disease
active infection
HBV hepatitis or carrier
uncontrolable hypertension
intestinal pneumonia
past history of intake aboutimmunosuppressive agents
tubeluclosis
cardiac disease
pregnancy
13
1st name | |
Middle name | |
Last name | Kobayashi Noritoshi |
Yokohama City University Hospital
Clinical Oncology
3-9, Fuku-ura, Kanazawa-ku, Yokohama
045-787-2623
norikoba@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Kobayashi Noritoshi |
Yokohama City University Hospital
Clinical Oncology
3-9, Fuku-ura, Kanazawa-ku, Yokohama
045-787-2623
norikoba@yokohama-cu.ac.jp
Yokohama City University Hospital
Yokohama City University Hospital
Other
NO
2013 | Year | 04 | Month | 20 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 20 | Day |
2013 | Year | 04 | Month | 20 | Day |
2017 | Year | 04 | Month | 19 | Day |
primary end point
overall response
secondary end point
time to treatment failure
progression-free survival
overall survival
adverse events
2013 | Year | 04 | Month | 19 | Day |
2017 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012334
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Research case data | |
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