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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025464
Receipt No. R000029301
Scientific Title Docetaxel, cisplatin and S-1 (DCS) combination chemotherapy for gastric cancer patients with peritoneal metastasis: retrospective study
Date of disclosure of the study information 2016/12/28
Last modified on 2016/12/28

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Basic information
Public title Docetaxel, cisplatin and S-1 (DCS) combination chemotherapy for gastric cancer patients with peritoneal metastasis: retrospective study
Acronym DCS combination chemotherapy for gastric cancer patients with peritoneal metastasis: retrospective study
Scientific Title Docetaxel, cisplatin and S-1 (DCS) combination chemotherapy for gastric cancer patients with peritoneal metastasis: retrospective study
Scientific Title:Acronym DCS combination chemotherapy for gastric cancer patients with peritoneal metastasis: retrospective study
Region
Japan

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

Objectives
Narrative objectives1 We retrospectively investigate the activity and toxicity of docetaxel, cisplatin and S-1 (DCS) combination chemotherapy in advanced gastric cancer patients with peritoneal metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes Response rate
Progression-free survival
Adverse events
Drug exposure

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) had a histologically proven gastric adenocarcinoma
(2) had a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group scale
(3) aged 20-80 years
(4) received DCS as first-line therapy for either metastatic or unresectable disease, with PM confirmed by image diagnosis such as computed tomography (CT), macroscopic evaluation or cytology
(5) no prior chemotherapy other than adjuvant chemotherapy, which was required to have been completed 6 months before enrollment
(6) received no other concomitant targeted therapy, such as trastuzumab
(7) had documented follow-up with a physician and a radiographic tumor evaluation
(8) showed adequate bone marrow, liver, and renal function
(9) no other serious medical conditions
(10) life expectancy 3 months
(11) not pregnant or breast-feeding
(12) provided written, informed consent.
Key exclusion criteria (1)Patients with active double cancer
(2) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Ohnuma
Organization Sapporo Medical University School of Medicine
Division name Department of Medical Oncology
Zip code
Address S1W16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email ohnuma@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Ohnuma
Organization Sapporo Medical University School of Medicine
Division name Department of Medical Oncology
Zip code
Address S1W16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Homepage URL
Email ohnuma@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine, Department of Medical Oncology
Institute
Department

Funding Source
Organization none
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
2016 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 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 We retrospectively evaluated the activity and toxicity of docetaxel, cisplatin and S-1 (DCS) combination chemotherapy in advanced gastric cancer patients with peritoneal metastasis. Of the 111 AGC patients who received DCS, PM was detected in 37 cases.

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2016 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029301

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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