UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004578
Receipt number R000005467
Scientific Title Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.
Date of disclosure of the study information 2010/12/01
Last modified on 2017/07/04 09:26:39

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Basic information

Public title

Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.

Acronym

Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.(JFMC43-1003)

Scientific Title

Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.

Scientific Title:Acronym

Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.(JFMC43-1003)

Region

Japan


Condition

Condition

Advanced or recurrent gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate clinical usefulness of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression Free Survival

Key secondary outcomes

Safety, Overall Survival, Time to Treatment Failure, Disease Control Rate and Response Rate


Base

Study type

Interventional


Study design

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


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Daily administrations: TS-1 is administered orally for 28 days, followed by 14 days rest.

Interventions/Control_2

Alternate-day administrations: TS-1 is administered orally at Monday, Wednesday, Friday and Sunday.

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) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma.
2) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
3) No prior radiotherapy, chemotherapy or hormone therapy.
4) Adequate organ functions:
i) WBC >=3000/mm3 and <=12000/mm3,
ii) neutrophils >=2000/mm3,
iii) platelets >=100,000/mm3,
iv) hemoglobin >=8.0g/dL,
v) total bilirubin <=1.5mg/dL,
vi) AST(GOT)/ALT(GPT) <=100IU/L,
vii) creatinine clearance >=50mL/min.
5) ECOG Performance status:0-2
6) Expected survival over 3 months.
7) Age of 20 years or older.
8) Sufficient oral intake.
9) Normal ECG.
10) Written informed consent.

Key exclusion criteria

1) Limitation of use of TS-1.
2) Infection and inflammation.
3) Serious heart disease.
4) Symptomatic pulmonary fibrosis or interstitial pneumonia.
5) Severe complications, such as ileus, uncontrolled diabetes mellitus, heart failure, renal failure and hepatocirrhosis.
6) A large amount of pleural effusion or peritoneal fluid.
7) Widespread bone-marrow metastases.
8) Brain metastasis.
9) Fresh bleeding from digestive organs.
10) Diarrhea.
11) Severe mental disorders.
12) Active synchronous malignancy.
13) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
14) Pregnant females, possibly pregnant
females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
15) Other patients who are unfit for the study as determined by the attending physician.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirakawa Kosei

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Surgical Oncology

Zip code


Address

1-4-3 Asahimachi, Abeno-ku, Osaka City ,Osaka 545-8585 JAPAN

TEL

06-6645-3838

Email



Public contact

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

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


Sponsor or person

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name



Funding Source

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

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

2010 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://dx.doi.org/10.1007/s10147-017-1157-3

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

Completed

Date of protocol fixation

2010 Year 07 Month 26 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 11 Month 17 Day

Last modified on

2017 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005467


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name