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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032364
Receipt No. R000036912
Scientific Title A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Date of disclosure of the study information 2018/05/07
Last modified on 2018/04/24

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Basic information
Public title A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Acronym A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Scientific Title A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisayuki Matsushita
Organization Tochigi Cancer Center
Division name Department of Esophageal and Gastric surgery
Zip code
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
1st name
Middle name
Last name Noriko Oshima
Organization Tochigi Cancer Center
Division name Department of Esophageal and Gastric surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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