UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Title of the study (Brief title)	A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of laparoscopic gastrectomy with D2 lymph node dissection for advanced gastric cancer (cT2N1/N2 or cT3N0/N1/N2)
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of intra-abdominal infectious complications (anastomotic leakage, pancreatic fistula, and intra-abdominal abscess)
Key secondary outcomes	The proportion of conversion to open surgery, and the incidence of adverse events

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	Maneuver
Interventions/Control_1	laparoscopic gastrectomy with D2 lymph node dissection
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) Histologically proven adenocarcinoma. (2) Clinical T1N1/N2 or cT3N0/N1/N2 by imaging. (3) Tumor located in the middle or lower third of the stomach, and curative resection is expected to be achievable by distal gastrectomy. (4) The macroscopic tumor type neither Borrmann type 4 nor large (8cm or more) type 3 (5) No bulky lymph nodes (>=3 cm x 1 or >=1.5 cm x 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein by contrast-enhanced abdominal computed tomography. (6) No distant metastasis based on contrast-enhanced thoracic/abdominal/pelvic CT. (7) No duodenal invasion (8) Age between 20 and 80 years old (9) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. (10) Body Mass Index (BMI) <30 (11) No history of intestinal resection except appendectomy and cholecystectomy (12) No prior chemotherapy, radiotherapy or endocrine therapy (13) Without main organ failure (14) Adequate organ functions defined as indicated below; (a) WBC >= 3,000/mm3 (b) Platelet >= 100,000/mm3 (c) AST <= 100IU/L , ALT <= 100IU/L (d) Total bilirubin <= 2.0 mg/dL (e) Creatinine <= 1.5 mg/dL (15) Written informed consent (16) Patients evaluated to be adequate to participate in this study by the conference in our center.
Key exclusion criteria	(1) History of upper abdominal surgery. (2) Insufficient oral intake. (3) With active infectious disease requiring systemic treatment. (4) The body temperature of 38 degrees Celsius or higher. (5) Pregnant or possibly pregnant, or lactating female (6) Impossible to register for the study due to a psychological disorder by a physician in charge's decision (7) Under continuous steroids medication (8) With unstable angina pectoris within three weeks or history of myocardial infarction within six months (9) With uncontrollable blood hypertension (10) With uncontrollable diabetes mellitus or routine administration of insulin (11) With pulmonary disease and require continuous oxygen therapy
Target sample size	80

Research contact person
Name of lead principal investigator	Hisayuki Matsushita
Organization	Tochigi Cancer Center
Division name	Department of Esophageal and Gastric surgery
Address	4-9-13, Yohnan, Utsunomiya, Tochigi, 320-0834, Japan
TEL	028-658-5151
Email	hmatsush@tochigi-cc.jp

Public contact
Name of contact person	Noriko Oshima
Organization	Tochigi Cancer Center
Division name	Department of Esophageal and Gastric surgery
Address	4-9-13, Yohnan, Utsunomiya, Tochigi, 320-0834, Japan
TEL	028-658-5151
Homepage URL
Email	norooshi@tochigi-cc.jp

Sponsor
Institute	Tochigi Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2018 Year 05 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 13 Day
Anticipated trial start date	2018 Year 05 Month 07 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

Management information
Registered date	2018 Year 04 Month 24 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036912