UMIN-CTR Clinical Trial

Public title

Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC)

Acronym

Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC) (JFMC36-0701)

Scientific Title

Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC)

Scientific Title:Acronym

Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC) (JFMC36-0701)

Region

Japan

Condition

Advanced or recurrent gastric cancer (AGC)

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the superiority of a combination of S-1 and Lentinan compared to S-1 in advanced or recurrent gastric cancer in terms of survival benefit

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

overall survival

Key secondary outcomes

TTF, adverse events, QOL, tumor response

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TS-1 alone : TS-1 is administered orally at the dose of 80mg/m2/day for 28 days, followed by 14 days rest.

Interventions/Control_2

TS-1+ Lentinan : TS-1 is administered orally at the dose of 80mg/m2/day for 28 days, followed by 14 days rest, and lentinan is administered intravenously at the dose of 2mg in a week.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma
2) If measurable lesions exist, these have to be evaluated within 28 days before registration
3) No prior therapy
4) Sufficient organ functions
5) Performance Status (ECOG scale) : 0-2
6) Expected survival over 3 months
7) Oral intake is possible
8) Written informed consent

Key exclusion criteria

1) Limitation of use of TS-1 or Lentinan
2) Infection and inflammation
3) Serious heart disease
4) Serious coexisting illness
5) A large amount of pleural effusion or peritoneal fluid
6) Broad bone metastasis
7) Brain metastasis
8) Fresh bleeding from digestive organs
9) Diarrhea
10) Severe mental disorders
11) Active synchronous malignancy
12) Pregnant or nursing
13) Not suitable for participating in this study for any other reason

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Masaaki Oka

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Digestive Surgery and Surgical Oncology

Zip code

Address

1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Division name

Office

Zip code

Address

TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan

TEL

03-5627-7594

Homepage URL

http://www.jfmc.or.jp/

Email

jfmc-dc@jfmc.or.jp

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

2007

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://dx.doi.org/10.1016/j.ejca.2016.06.012

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

Completed

Date of protocol fixation

2006

Year

12

Month

07

Day

Date of IRB

Anticipated trial start date

2007

Year

02

Month

01

Day

Last follow-up date

2012

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

01

Month

16

Day

Last modified on

2016

Year

08

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000696