Unique ID issued by UMIN | UMIN000006591 |
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Receipt number | R000007800 |
Scientific Title | Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer. -Phase II study- |
Date of disclosure of the study information | 2011/10/22 |
Last modified on | 2013/11/13 12:02:18 |
Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer. -Phase II study-
XP+HER for previously untreated HER2 positive advanced gastric cancer. -Phase II study-
Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer. -Phase II study-
XP+HER for previously untreated HER2 positive advanced gastric cancer. -Phase II study-
Japan |
untreated HER2 positive advanced gastric cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Adult |
Malignancy
NO
Evaluation of the efficacy and safety of capecitabine plus cisplatin plus trastuzumab for previously untreated HER2 positive advanced gastric cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
PFS: Progression Free Survival
ORR:Overall Response Rate
DCR:Disease Control Rate
OS:Overall Survival
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
XP+HER(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 and Trastuzumab 8 or 6 mg/kg q3w)
20 | years-old | <= |
Not applicable |
Male and Female
(1) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma (included EGJ cancer)
(2) Positive HER2 status(IHC3+ or IHC2+/FISH+)
(3) Written informed conscent to receive this chemotherapy.
(4) 70 years old or more than 70 years old.
(5) Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
(6) Life expectancy of at least 3 months after registration.
(7) Case which has lesions to be evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline.
(8) Adequate organ function as follows:
1. WBC count 4,000-12,000/mm3
2. Neutrophils count more than 1,500/mm3
3. Platelet count more than 100,000/mm3
4. Hemoglobin more than 8.0 g/dl
5. Serum bilirubin level less than 1.5 mg/dl
6. Ast and ALT less than 100 IU/l
7. Serum creatinine level less than 1.2 mg/dl
8. Creatinine clearance more than 30mL/min
9. LVEF more than 50%
(9) Patient who is possible of ingestion.
(10) Without previous chemotherapy (except adjuvant chemotherapy exclude cisplatin).
(1) Forbidden case to use capecitabine, Cisplatin and Trastuzumab.
(2) R1 operation(histlogically positive PM, OM, LM, VM).
(3) Infection or inflammatory case.
(4) Severe heart disease.
(5) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc.
(6) Severe ascites and/or pleural effusion.
(7) Multiple bone metastasis.
(8) Clinical suspicion or previous history of metastasis to brain or meninges.
(9) Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage.
(10)Complicated other active cancer.
(11)patient who want to be pregnant and /or pregnant woman.
(12)Intend to make pregnant.
(13)Active hepatitis type HBs positive.
(14)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.
25
1st name | |
Middle name | |
Last name | Noriyuki Hirahara, M.D., Ph.D. |
Shimane University Hospital
Digestive and General Surgery
89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
0853-20-2232
norinori@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Noriyuki Hirahara, M.D., Ph.D. |
Shimane University Hospital
Digestive and General Surgery
89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
0853-20-2232
norinori@med.shimane-u.ac.jp
SGCSG: Shimane Gastroenterological Cancer Study Group
SGCSG: Shimane Gastroenterological Cancer Study Group
Self funding
NO
2011 | Year | 10 | Month | 22 | Day |
Unpublished
Open public recruiting
2011 | Year | 08 | Month | 25 | Day |
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 22 | Day |
2013 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007800
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