UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025464 |
|---|---|
| Receipt number | 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 18:59:14 |
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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
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
ohnuma@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine, Department of Medical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029301
