UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019544
Receipt number R000019623
Scientific Title Investigation of multimodality treatment for unresectable or recurrent gastric cancer
Date of disclosure of the study information 2015/11/01
Last modified on 2021/05/02 22:15:37

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Basic information

Public title

Investigation of multimodality treatment for unresectable or recurrent gastric cancer

Acronym

Investigation of multimodality treatment for unresectable or recurrent gastric cancer

Scientific Title

Investigation of multimodality treatment for unresectable or recurrent gastric cancer

Scientific Title:Acronym

Investigation of multimodality treatment for unresectable or recurrent gastric cancer

Region

Japan


Condition

Condition

unresectable or recurrent gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of the research is to clarify the meanings and timings of operation and radiotherapy for unresectable or recurrent gastric cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Survival

Key secondary outcomes

Side effects of chemotherapy, perioperative complication


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

unresectable or recurrent gastric cancer

Key exclusion criteria

Patients with other malignant tumor with poorer survival.
Patients who decline the offer to use the data.

Target sample size

250


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Kakeji

Organization

Kobe University

Division name

Division of Gastrointestinal Surgery

Zip code

6500017

Address

Kusunoki-chou 7-5-2, Chuo-ku, Kobe

TEL

078-382-5925

Email

kakeji@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Suzuki

Organization

Kobe University

Division name

Division of Gastrointestinal Surgery

Zip code

6500017

Address

Kusunoki-chou 7-5-2, Chuo-ku, Kobe

TEL

078-382-5925

Homepage URL


Email

ss147@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe

Tel

078-382-5014

Email

rinri@med.kobe-u.ac.jp


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

2015 Year 11 Month 01 Day


Related information

URL releasing protocol

https://www.med.kobe-u.ac.jp/surg1/shinryou/igan.html

Publication of results

Published


Result

URL related to results and publications

https://ar.iiarjournals.org/content/38/4/2363.long

Number of participants that the trial has enrolled

127

Results

Multivariate analysis showed that gastrectomy,performance status 0/1, differentiated type, absence of distant organ metastasis, and second line chemotherapy was a prognostic factor. Among the patients with gastrectomy, R0 resection was a prognostic factor. R0 resection was mainly achieved when there was a single non-curable factor and no distant organ metastasis.

Results date posted

2021 Year 05 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Unresectable gastric cancer

Participant flow

Patients were recruited retrospectively

Adverse events

none

Outcome measures

overall survival

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 19 Day

Date of IRB

2015 Year 10 Month 19 Day

Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a cohort study. Patients who were diagnosed as unresectable or recurrence of gastric cancer from 2015/11/1 to 2020/12/31 are calculated to this study.
The endpoints are as follows.
1. Treatment (chemotherapy only, chemotherapy after operation, operation after chemotherapy, with of without radiation therapy)
2. death investigation (date of death, cause of death)
3. selected chemotherapy and numbers of course
4. side-effects of chemotherapy according to the CTCAE guidelines.(RBC, Hb, WBC, Plt, TP, Alb, AST, ALT, gamma GTP, BUN, Cr)
5. timing of operation and operation method
6. operative complications according to the Clavien-Dindo classification.


Management information

Registered date

2015 Year 10 Month 28 Day

Last modified on

2021 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019623


Research Plan
Registered date File name
2017/10/30 1.No.1771鈴木(音羽)20150811.xls

Research case data specifications
Registered date File name

Research case data
Registered date File name