UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013185
Receipt number R000015242
Scientific Title Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer
Date of disclosure of the study information 2014/02/18
Last modified on 2016/06/30 15:24:45

* 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

Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer

Acronym

Study of Alternate-day administrations of TS-1 for resected Colorectal Cancer

Scientific Title

Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer

Scientific Title:Acronym

Study of Alternate-day administrations of TS-1 for resected Colorectal Cancer

Region

Japan


Condition

Condition

Stage III colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of daily administrations and alternate-day administrations of TS-1 in curatively resected Stage III colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Treatment Completion Rate

Key secondary outcomes

3-year Disease-Free Survival
Overall Survival
Compliance
Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Standard Arm(Daily administrations)
TS-1 is administered orally for 28 days, followed by 14 days rest. Administrations are conducted for 24 weeks from the date of the start of the therapy. After the treatment, patients are simply observed without any more therapy, unless any recurrent lesions or any other cancer lesions are observed in them.

Interventions/Control_2

Testing Arm(Alternate-day administrations)
TS-1 is administered orally at Monday, Wednesday, Friday and Sunday.
Administrations are conducted for 28 weeks from the date of the start of the therapy. After the treatment, patients are simply observed without any more therapy, unless any recurrent lesions or any other cancer lesions are observed in them.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Histologically proven, Stage III, (Japanese Classification of Colorectal cancer 8th Edition) primary Colon cancer or RS.
2)Curability A
3)Age between 20 and 80 years.
4)Performance status(ECOG) of 0-1.
5)No prior therapy expect the operation.
6)Capability of oral intake
7)Patients who have satisfied the clinical test values within 14 days before the registration.
8)Patient with starting the treatment within 8 weeks after operation.
9)Written informed consent.

Key exclusion criteria

1)Active double cancer
2)Synchronous or metachronous malignancy other than carcinoma in situ.
3)Severe postoperative complications.
4)Severe complication.
5)Severe diarrhea.
6)Severe infectious disease.
7)Medical history of severe anaphylaxis or allergia to any drug.
8)Undergoing treatment with fluorocytosine.
9)Hepatitis B virus infection, hepatitis C virus infection.
10)Women who are pregnant or breast-feeding, or Women who may become pregnant and fertile men.
11)Severe mental disorder.
12)Patients judged inappropriate for the study by their physicians.

Target sample size

170


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chu Matsuda

Organization

Osaka General Medical Center

Division name

Surgery

Zip code


Address

3-1-56,Bandaihigashi, Sumiyoshi-ku, Osaka

TEL

06-6692-1201

Email

chu0219pinefield@gh.opho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taishi Hata

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3251

Homepage URL


Email

thata@gesurg.med.osaka-u.ac.jp


Sponsor or person

Institute

Clinical Study Group of Osaka (CSGO), Colorectal Cancer Treatment Group

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


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

2014 Year 02 Month 18 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

Terminated

Date of protocol fixation

2014 Year 02 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2015 Year 07 Month 24 Day

Date of closure to data entry

2015 Year 07 Month 24 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 18 Day

Last modified on

2016 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015242


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/01/09 大腸癌術後補助化学療法におけるTS-1の投与方法に関するrandomized Phase II trial.zip