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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005603
Receipt No. 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

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Basic information
Public title Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Acronym Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Scientific Title Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Scientific Title:Acronym Feasibility study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes feasibility
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with docetaxel (50mg/m2), CDDP (60mg/m2), S-1 (80mg/m2) and trastuzumab (6mg/kg) combination chemotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Takayama
Organization Tokushima University Hospital
Division name Department of Gastroenterology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city
TEL 088-633-7124
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Miyamoto
Organization Tokushima University Hospital
Division name Department of Gastroenterology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city
TEL 088-633-7124
Homepage URL
Email miyamoto.hiroshi@tokushima-u.ac.jp

Sponsor
Institute Tokushima-Hokkaido cancer therapy clinical trial group
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 15 Day
Last modified on
2015 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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