UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognostic and effect predictive factors of multimodality treatment for gastric cancer
Title of the study (Brief title)	Prognostic and effect predictive factors of multimodality treatment for gastric cancer
Region	Japan South America

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

Objectives
Narrative objectives1	The aim of the research is to clarify the prognostic end effect predictive factors of multimodality treatment for the patients with gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Recurrence rate Progression free survival Overall objective response rate Side effects of chemotherapy perioperative complication

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Gastric cancer
Key exclusion criteria	Patients with poorer prognosis less than three months. Patients who decline the offer to use the data
Target sample size	500

Research contact person
Name of lead principal investigator	Masazumi Takahashi
Organization	Yokohama Municipal Citizen's Hospital
Division name	Division of Gastroenterological Surgery
Address	Okazawa-cho 56, hodogaya-ku, Yokohama
TEL	045-331-1961
Email	ma06-takahashi@city.yokohama.jp

Public contact
Name of contact person	Masazumi Takahashi
Organization	Yokohama Municipal Citizen's Hospital
Division name	Division of Gastroenterological Surgery
Address	Okazawa-cho 56, hodogaya-ku, Yokohama
TEL	045-331-1961
Homepage URL
Email	ma06-takahashi@city.yokohama.jp

Sponsor
Institute	Yokohama Municipal Citizen's Hospital, Division of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	Yokohama Municipal Citizen's Hospital
Organization
Division
Category of Funding Organization	Local Government
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	横浜市立市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 02 Month 13 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	This is a cohort study. Patients who were diagnosed as gastric cancer from 1999/4/1 to 2024/3/31 are calculated to this study. The endpoints are as follows. 1. Treatment (chemotherapy only, chemotherapy after operation, operation after chemotherapy, with of without radiation therapy) 2. Death investigation (date of death, cause of death) 3. Selected chemotherapy and numbers of course 4. Side-effects of chemotherapy according to the CTCAE guidelines.(RBC, Hb, WBC, Plt, TP, Alb, AST, ALT, gamma GTP, BUN, Crt %lymphocte, %monocyte 5. Prognostic and effect predictive factors, %lymphocte, %monocyte, %neutrocte, Number of Plt, CRP, sIL-2R, Alb 6. Timing of operation and operation method 7. Operative complications according to the Clavien-Dindo classification.

Management information
Registered date	2018 Year 01 Month 30 Day
Last modified on	2018 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035327