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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007783
Receipt No. R000009171
Scientific Title Clinical trial on the efficacy of the UFT/LV for the Stage II colorectal cancer with risk factors for recurrence
Date of disclosure of the study information 2012/05/07
Last modified on 2016/12/14

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Basic information
Public title Clinical trial on the efficacy of the UFT/LV for the Stage II colorectal cancer with risk factors for recurrence
Acronym Clinical trial on the efficacy of the UFT/LV for the Stage II colorectal cancer with risk factors for recurrence (JFMC46-1201)
Scientific Title Clinical trial on the efficacy of the UFT/LV for the Stage II colorectal cancer with risk factors for recurrence
Scientific Title:Acronym Clinical trial on the efficacy of the UFT/LV for the Stage II colorectal cancer with risk factors for recurrence (JFMC46-1201)
Region
Japan

Condition
Condition StageII colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the clinical effectiveness of the UFT/LV for the patients with Stage II colorectal cancer with risk factors of recurrence.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Disease-free survival
Key secondary outcomes Overall survival,
Adverse events,
Investigation of the efficacy for UFT/LV and the prognosis by the presence of CEA mRNA-positive later than 24 hours after surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
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 UFT/LV as postoperative adjuvant chemotherapy for the stage II colorectal cancer is tested as follows: one patient group for 28 days with 7 days rest (everyday medication) and another patient group for 5days with 2days rest (5-days on/2-days, Saturday and Sunday, off). Both medications are conducted for 25weeks as 5 courses (1 course=5weeks, 35days) from the date of the start of the therapy. After the treatment, both patient groups are simply observed without any more therapy, unless any recurrent lesions or any other cancer lesions are observed in them.
Interventions/Control_2 The surgery alone group is simply observed without therapy, unless any recurrent lesions or any other cancer lesions (synchronous cancers or multiple colorectal cancers) 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 A patient:
1)with histologically confirmed colorectal cancer.
2)with histologically confirmed StageII(T3-4,N0,M0)(TNM classification,UICC,Vol.7,2009)colorectal cancer(which is C,A,T,D or S)and rectal cancer(which is only RS).
3)has at least one of the following factors
-T4
-Perforation,Penetration
-Poorly differentiated adenocarcinoma
-Mucinous carcinoma
-Lymph node dissection:less than 12
4)underwent R0 resection.
5)is at the age of 20 to 80 at the time of registration.
6)whose Performance status(ECOG)is 0 or 1.
7)hasn't received any treatment other than R0 resection.
8)can take drugs orally.
9)whose sufficient functions of main organ should be confirmed by the clinical test within 14 days before registration as follows:
i)WBC:>=3,000/mm3,<12,000/mm3
ii)neutrophil:>=1,500/mm3
iii)blood platelet:>=100,000mm3
iv)hemoglobin:>=9.0g/dL
v)total bilirubin:=2.0mg/dL
vi)AST(GOT):<=100IU/L
vii)ALT(GPT):<=100IU/L
viii)Scr:<1.5mg/dL
10)can start the therapy within 8 weeks after surgery.
11)whose written consent is taken.
Key exclusion criteria A patient:
1)with administration contraindications for UFT,LV.
2)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years).
3)has severe postoperative complications
such as serious postoperative infectious disease,anastomotic leak and gastrointestinal bleeding.
4)has any of the following complications:
i)Uncontrollable diabetes mellitus
ii)Uncontrollable hypertension
iii)liver cirrhosis,liver failure
iv)renal failure
v)interstitial pneumonitis,lung fibrosis or severe emphysema
vi)active infection
vii)heart failure within 6 months,myocardial infarction,AP or sever abnormality of ECG
5)has severe diarrhea.
6)has severe drug hypersensitivity.
7)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant.
8)with psychosis or psychoneurosis.
9)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Target sample size 2820

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sotaro Sadahiro
Organization Tokai University School of Medicine
Division name Department of Surgery
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
TEL 0463-93-1121
Email sadahiro@is.icc.u-tokai.ac.jp

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, Koto-ku, Tokyo, 136-0071, Japan
TEL 03-5627-7594
Homepage URL http://www.jfmc.or.jp/
Email jfmc46@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 05 Month 07 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
2012 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 18 Day
Last modified on
2016 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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