UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Docetaxel, cisplatin and S-1 (DCS) combination chemotherapy for gastric cancer patients with peritoneal metastasis: retrospective study
Title of the study (Brief title)	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	Hiroyuki Ohnuma
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Address	S1W16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	ohnuma@sapmed.ac.jp

Public contact
Name of contact person	Hiroyuki Ohnuma
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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