UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029317
Receipt number R000033516
Scientific Title Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Date of disclosure of the study information 2017/10/01
Last modified on 2023/09/18 10:34:11

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Basic information

Public title

Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins

Acronym

Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins

Scientific Title

Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins

Scientific Title:Acronym

Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the equality in terms of proximal margins in laparoscopic distal gastrectomy against open distal gastrectomy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proximal margins

Key secondary outcomes



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

Perform laparoscopic distal gastrectomy for patients diagnosed as cT1N2-3, cT2N0-3, cT3N0, or cT4aN0 gastric cancer.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) The cancer is histologically proven adenocarcinoma of the stomach.
2) The cancer has been diagnosed as clinical T1N2-3, T2N0-3, T3N0, T4aN0, and cM0 with no bulky metastatic lymph nodes.
3) The patient is 20 years of age or older.
4) The patient has an Eastern Cooperative Oncology Group performance status of 0 to 2.
5) The patient has no history of treatment for gastric cancer.
6) The patient has a body mass index of less than 35 kg/m2.
7) Written informed consent is provided.

Key exclusion criteria

1) Patients with synchronous double cancer, metachronous double cancer (within 5 years) (except carcinoma in situ).
2) Patients with cT4b, cM1 gastric cancer
3) Patients who went under preoperative treatment for gastric cancer (except staging laparoscopy).
4) Patients with possibility of pregnancy.
5) Patients with mental disorder who are difficult to participate in the study.
6) Patients who are recieving steroid therapy.
7) Patients with viral, bacterial, and fungal infections who requires medical treatment.
8) Patients with poorly controlled diabetes.
9) Patients with unstable angina or myocardial infarction
10) Patients with respiratory disorder who requires oxygen inhalation.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Souya
Middle name
Last name Nunobe

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Division name

Department Gastroenterological Surgery

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

TEL

03-3520-0111

Email

souya.nunobe@jfcr.or.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Makuuchi

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Division name

Department Gastroenterological Surgery

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

TEL

03-3520-0111

Homepage URL


Email

rie.makuuchi@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Institute

Department

Personal name



Funding Source

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

Tel

03-3570-0210

Email

med.shinsa@jfcr.or.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2017-1049

Org. issuing International ID_1

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 10 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

2017 Year 09 Month 25 Day

Date of IRB

2017 Year 09 Month 27 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2027 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 27 Day

Last modified on

2023 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033516


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name