UMIN-CTR Clinical Trial

Public title

A Phase II study of laparoscopic gastrectomy for advanced gastric cancer

Acronym

A Phase II study of laparoscopic gastrectomy for advanced gastric cancer

Scientific Title

A Phase II study of laparoscopic gastrectomy for advanced gastric cancer

Scientific Title:Acronym

A Phase II study of laparoscopic gastrectomy for advanced gastric cancer

Region

Japan

Condition

Advanced gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety of laparoscopic gastrectomy for advanced gastric cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Grade 3 or higher surgical complications (Clavien-Dindo Classification)

Key secondary outcomes

Proportion of conversion to open surgery, performance of surgery, number of retrieved lymph node, adverse events, short-term clinical outcomes, completion rate of adjuvant chemotherapy, CEA mRNA in the peritoneal lavage fluid, overall survival, recurrence-free survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic gastrectomy

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 gastric carcinoma
(2)cStageII or III according to the Japanese Classification of Gastric Carcinoma [The 14th Edition]
(3)R0 resection or R1 resection solely by CY1 can be obtained
(4)Clinical H0, P0, M0
(5)No invasion to esophagus and duodenum
(6)No apparent invasion to adjacent organs
(7) No prior treatment of chemotherapy for gastric cancer
(8)The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3
(9) Aged 20 to 79 years
(10)Eastern Cooperative Oncology Group (ECOG) PS of 0-2
(11)Body mass index less than 30
(12)No obvious organ failures and satisfy the following laboratory data within 30 days before registration:
WBC >=3,000/mm3 WBC<12,000/mm3
Platelet >= 100,000/mm3
Hb >= 8.0 g/dL
AST <= local reference range 2
ALT <= local reference range 2
T.Bil <= 2.0 mg/dL
Creatinin <= 1.5 mg/dL
(13)No history of upper abdominal surgery and no history of intestinal resection.
(14)No prior treatment of chemotherapy or radiation therapy against any other malignancies.
(15)provided written informed consent

Key exclusion criteria

(1)Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
(2)Active infection disease
(3)Over 38.0 degree Celsius
(4)Women during pregnancy or breast-feeding.
(5)Severe mental disease.
(6)Continuous systemic steroid therapy.
(7)History of myocardial infarction or unstable angina pectoris within six months.
(8)Uncontrollable hypertension.
(9)Uncontrollable diabetes millutus or administration of insulin.
(10)Severe respiratory disease requiring continuous oxygen therapy.
(11)Kidney failure requiring hemodialysis or peritoneal dialysis

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Yuichiro Doki

Organization

Osaka University School of Medicine

Division name

Gastroenterological Surgery

Zip code

Address

2-2 Yamadaoka Suita City Osaka

TEL

06-6879-3251

Email

ydoki@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Atsushi Gakuhara

Organization

Osaka University School of Medicine

Division name

Gastroenterological Surgery

Zip code

Address

2-2 Yamadaoka Suita City Osaka

TEL

06-6879-3251

Homepage URL

Email

agakuhara@gesurg.med.osaka-u.ac.jp

Institute

Department of Gastroenterological Surgery, Osaka University School of Medicine

Institute

Department

Personal name

Organization

Osaka University Clinical Research Group for Gastroenterological Study

Organization

Division

Category of Funding Organization

Self funding

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

大阪大学医学部附属病院（大阪府）、大阪府立成人病センター（大阪府）、大阪警察病院（大阪府）

Date of disclosure of the study information

2017

Year

01

Month

31

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

No longer recruiting

Date of protocol fixation

2016

Year

12

Month

13

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

18

Day

Last modified on

2019

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029609