UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008961 |
|---|---|
| Receipt number | R000010509 |
| Scientific Title | Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy for the Stage II, III colorectal cancer |
| Date of disclosure of the study information | 2012/09/25 |
| Last modified on | 2014/03/25 17:17:14 |
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Basic information
Public title
Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy for the Stage II, III colorectal cancer
Acronym
Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy.
(KODK8)
Scientific Title
Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy for the Stage II, III colorectal cancer
Scientific Title:Acronym
Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy.
(KODK8)
Region
| Japan |
Condition
Condition
resectable StageII, III colorectal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the QOL with StageII, III patients for resectable colorectal cancer using Tegafur/Uracil plus Leucovolin(UFT/LV) therapy.
Basic objectives2
Others
Basic objectives -Others
Quality of Life
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Quality of Life
Key secondary outcomes
Adverse event 3-year Disease free survival ratio
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tegafur/uracil with oral leucovorin(UFT/LV)
UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest.
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
1)with histologically confirmed StageII, III colorectal cancer
2)with histologically confirmed colorectal cancer.
3)underwent R0 resection.
4)is at the age of 20 to 80 at the time of registration.
5)whose Performance status(ECOG)is 0 or 1.
6)can take drugs orally
7)whose sufficient functions of main organ should be confirmed by the clinical test within 14 days before registration as follows:
i)WBC:>=3,500/mm3,<12,000/mm3
ii)neutrophil:>=1,500/mm3
iii)hemoglobin:>=9.0g/dL
iv)blood platelet:>=100,000mm3
v)total bilirubin:=2.0mg/dL
vi)AST(GOT):<=100IU/L
vii)Scr:<1.2mg/dL
8)can start the therapy within 8 weeks after surgery.
9)whose written consent is taken.
Key exclusion criteria
1)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years).
(2)Synchronous or metachronous malignancy other than carcinoma in situ
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) heart failure within 6 months,myocardial infarction,AP or sever abnormality of ECG
iv)renal failure
v)interstitial pneumonitis,lung fibrosis or severe emphysema .
5)has any of the following :
i)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant
ii)nursing women
6)with psychosis or psychoneurosis.
7)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Hasegawa |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
03-3353-2681
hasegawa@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyosi Okabayashi |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
03-3353-2681
Homepage URL
okabayashikoji@gmail.com
Sponsor or person
Institute
Department of Surgery
Keio University School of Medicine
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)
None
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | 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 | 09 | Month | 23 | Day |
Last modified on
| 2014 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010509
