UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer
Acronym	RDG phase II
Scientific Title	A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer
Scientific Title:Acronym	RDG phase II
Region	Japan

Condition
Condition	Patients with Stage IA and IB gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify safety of robot assisted distal and total gastrectomy with lymph node dissection
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)
Key secondary outcomes	Oveall survival Relapse free survival Completion rate of robot assised surgery The incidence of adverse event

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	Device,equipment
Interventions/Control_1	Robot assisted surgery
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) Biopsy specimen from the primary lesion shows adenocarcinoma 2) Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography 3) Endoscopic submucosal dissection is not indicated 4) Tumor was located within lower two thirds of stomach 5) Not having duodenal invasion 6) Eeatern clinical oncology group performans status is 0 or 1 7) Body mass index is lower than 30 8) No previous laparotomy 9) No previous chemotherapy or radiation including those for other cancers 10) Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl
Key exclusion criteria	1) Having other active cancers 2) Possibly pregnant, or breast feeding woman 3) with psychiatric disorder 4) Receiving steroids 5) With Acute myocardial infaction in 6 months or with unstable ungina 6) With uncontrolled hypertention 7) With uncontrolled diabetes mellitus 8) With pulmonary disease and require continuous oxygen therapy
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Kawashima
Organization	Saitama Cancer Center
Division name	Division of Gastric Surgery
Zip code	362-0806
Address	780, Komuro, Ina-city, Kita-Adachi-gun, Saitama, Japan
TEL	048-722-1111
Email	ykawashima@cancer-c.pref.saitama.jp

Public contact
Name of contact person	1st name Ehara Middle name Last name Kazuhisa
Organization	Saitama Cancer Center
Division name	Division of Gastric Surgery
Zip code	362-0806
Address	780, Komuro, Ina-city, Kita-Adachi-gun, Saitama, Japan
TEL	048-722-1111
Homepage URL	http://www.saitama-cc.jp/userinfo/clinical-trial.html
Email	kehara@cancer-c.pref.saitama.jp

Sponsor
Institute	Saitama Cancer Center
Institute
Department

Funding Source
Organization	Saitama Cancer Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saitama Cancer Center
Address	780, Komuro, Ina-city, Kita-Adachi-gun, Saitama, Japan
Tel	0487221111
Email	sccctmo01@cancer-c.pref.saitama.jp

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	埼玉県立がんセンター（埼玉県）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 01 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	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date	2014 Year 05 Month 22 Day
Last follow-up date	2019 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 05 Month 01 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016169