Unique ID issued by UMIN | UMIN000005603 |
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Receipt number | R000006622 |
Scientific Title | Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer |
Date of disclosure of the study information | 2011/06/15 |
Last modified on | 2015/12/08 16:59:19 |
Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Japan |
gastric cancer
Gastroenterology |
Malignancy
NO
To investigate feasibility, efficacy and safety of DCS-T (docetaxel 50mg/m2, CDDP 60mg/m2, S-1 80mg/m2, trastuzumab 6mg/kg) for HER2 positive unresectable metastatic gastric cancer
Safety,Efficacy
feasibility
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Treatment with docetaxel (50mg/m2), CDDP (60mg/m2), S-1 (80mg/m2) and trastuzumab (6mg/kg) combination chemotherapy
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Written informed consent.
2)Histologicaly (cytologically) proven gastric cancer.
3)HER2 positive by IHC or FISH method
4)Unresectable gastric cancer.
5)To have measurable lesions.
6)No prior chemotherapy or no influence of prior therapy.
7)Tolerable function of bone marrow, liver and kidney.
8)LVEF more than 50%
9)PS 0 - 1.
10)Expected survival for 3 months.
11)Possible oral intake.
1)History of hypersensitivity to DCS.
2)Contraindication to TXT, CDDP, S-1, G-CSF.
3)Infectious disease.
4)Severe compliaction.
5)Neuropathy greater than grade 2.
6)Brain metastasis with clinical symptoms.
7)Watery diarea.
8)Active double cancer.
9)Persons to be pregnant or to make pregnant.
16
1st name | |
Middle name | |
Last name | Tetsuji Takayama |
Tokushima University Hospital
Department of Gastroenterology
3-18-15, Kuramoto-cho, Tokushima city
088-633-7124
takayama@tokushima-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Miyamoto |
Tokushima University Hospital
Department of Gastroenterology
3-18-15, Kuramoto-cho, Tokushima city
088-633-7124
miyamoto.hiroshi@tokushima-u.ac.jp
Tokushima-Hokkaido cancer therapy clinical trial group
Self-funding
Self funding
NO
2011 | Year | 06 | Month | 15 | Day |
Published
The study included 16 patients: median age, 60 (34-76) years; males/females, 11:5; intestinal-type/diffuse-type histology, 11:5; and HER2 3+/2+(FISH+), 13:3. The completion rate until the third cycle was 87.5 % (14/16) (95 %CI 71.3-103.7 %). Adverse events of grade 3/4 severity during the first 3 cycles were: leukopenia/neutropenia, 50.0:75.0 %; febrile neutropenia, 12.5 %; diarrhea, 12.5 %; and stomatitis, 12.5 %. All of these side effects were manageable and well controlled. There were no treatment-related deaths. The overall response rate was 93.8 % (15/16), and the response rate in patients with measurable lesions was 100 % (15/15). The median cycle to response was only 1 (1-3 cycles). Non-curative factors disappeared in 56.3 % (9/16) of patients, and conversion surgery (R0 resection) was performed in all these cases. Pathological response rates in primary and metastatic lesions were 88.9 % (8/9) and 100 % (9/9), respectively. The median PFS and OS were not reached during the median follow-up time of 18.3 months ranged from 11.0 to 34.3 months.
Completed
2011 | Year | 05 | Month | 16 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 05 | Month | 15 | Day |
2015 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006622
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