UMIN-CTR Clinical Trial

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

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tochigi Cancer Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

04

Month

24

Day

Last modified on

2018

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036912