UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019519
Receipt number R000022575
Scientific Title A pooled data analysis of four randomized phase III trials (SPIRITS, GC0301/TOP-002, START, G-SOX) using individual patient data in advanced gastric cancer.
Date of disclosure of the study information 2015/10/28
Last modified on 2018/03/08 08:50:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A pooled data analysis of four randomized phase III trials (SPIRITS, GC0301/TOP-002, START, G-SOX) using individual patient data in advanced gastric cancer.

Acronym

A pooled data analysis of advanced gastric cancer

Scientific Title

A pooled data analysis of four randomized phase III trials (SPIRITS, GC0301/TOP-002, START, G-SOX) using individual patient data in advanced gastric cancer.

Scientific Title:Acronym

A pooled data analysis of advanced gastric cancer

Region

Japan Asia(except Japan)


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To analyze prognostic and to investigate the prognosis factor by the data of four randomized controlled trials (SPIRITS, GC0301/TOP-002, START, G-SOX).
Clinical trials number
- SPIRITS: ClinicalTrials.gov number: NCT00150670
- GC0301/TOP-002: JapicCTI-050083
- START: ClinicalTrials.gov number: NCT00287768
- G-SOX: JapicCTI-101021

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

(1) OS: Overall Survival
(2) PFS: Progression-Free Survival
(3) To evaluate the prognosis factor
(4) To evaluate the correlation between OS and PFS
(5) To evaluate the correlation between Tumor srinkage and OS, between Tumor srinkage and PFS
(6) To evaluate the correlation between Post Progression Free Survival and first line treatment
(7) To evaluate the correlation between Relative Dose Intensity and prognosis

Key secondary outcomes

In addition, other exploratory data analysis


Base

Study type

Others,meta-analysis etc


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


Not applicable

Gender

Male and Female

Key inclusion criteria

All cases who registered and analyzed in four randomized controlled study of advanced gastric cancer.

Key exclusion criteria

Any cases who registered other randomized studies or phase I or II studies.

Target sample size

1700


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Fujii

Organization

Nihon University School of Medicine

Division name

Devision of Digestive Surgery

Zip code


Address

30-1, Oyaguchikamimachi, Itabashi, Tokyo, Japan

TEL

03-3972-8111

Email

masashi.fujii@gioncology.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Fujii

Organization

Japan Clinical Cancer Research Organization

Division name

Office

Zip code


Address

7F, 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan

TEL

03-5579-9882

Homepage URL


Email

masashi.fujii@gioncology.jp


Sponsor or person

Institute

Japan Clinical Cancer Research Organization

Institute

Department

Personal name



Funding Source

Organization

Japan Clinical Cancer Research Organization

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2015 Year 10 Month 28 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

2015 Year 09 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To analyze prognostic and to investigate the prognosis factor by the data of four randomized controlled trials (SPIRITS, GC0301/TOP-002, START, G-SOX).
Clinical trials number
- SPIRITS: ClinicalTrials.gov number: NCT00150670
- GC0301/TOP-002: JapicCTI-050083
- START: ClinicalTrials.gov number: NCT00287768
- G-SOX: JapicCTI-101021
(1) OS: Overall Survival
(2) PFS: Progression-Free Survival
(3) To evaluate the prognosis factor
(4) To evaluate the correlation between OS and PFS
(5) To evaluate the correlation between Tumor srinkage and OS, between Tumor srinkage and PFS
(6) To evaluate the correlation between Post Progression Free Survival and first line treatment
(7) To evaluate the correlation between Relative Dose Intensity and prognosis
(8) In addition, exploratory data analysis


Management information

Registered date

2015 Year 10 Month 27 Day

Last modified on

2018 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name