UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005594 |
|---|---|
| Receipt number | R000006615 |
| Scientific Title | A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen) |
| Date of disclosure of the study information | 2011/05/18 |
| Last modified on | 2021/05/25 15:54:15 |
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Basic information
Public title
A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)
Acronym
A study on taking method of Tegafur-Uracil and Leucovorin Calcium (Three times-daily regimen Versus twice-daily regimen)
Scientific Title
A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)
Scientific Title:Acronym
A study on taking method of Tegafur-Uracil and Leucovorin Calcium (Three times-daily regimen Versus twice-daily regimen)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of UFT/LV in a twice-daily regimen as compared to in a three times-daily regimen for an adjuvant therapy in patients with stage II/III colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
3-year Disease-free survival
Key secondary outcomes
Overall survival
Adverse events,
Completion rate of treatment
Compliance
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group(three taimes-daily)
UFT was administered at a dose of 300 mg/m2/day, and LV was administered at a dose of 75 mg/day. The daily doses of both UFT and LV were divided into three doses administered 8 hours apart and taken together along with water. Repeat five 35-day cycles consisting of 28- day of oral chemotherapy administration and then a 7-day rest period.
Interventions/Control_2
B group(twice-daily)
UFT was administered at a dose of 300 mg/m2/d, and LV was administered at a dose of 50 mg/day. The daily doses of both UFT and LV were divided into twice doses and taken together along with water. Repeat five 35-day cycles consisting of 28- day of oral chemotherapy administration and then a 7-day rest period.
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 II, III, (Japanese Classification of Colorectal cancer 7th Ehition) primary Colorectal adenocarcinoma (eliminating appendiceal cancer).
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 following the clinical test values within two weeks before the registration.
1.Neutrophile:>= 1,500/mm3
2.Platelet:>= 100,000/mm3
3.Hemoglobin:>= 9.0g/dL
4.Total bilirubin: < 2.0 mg/dL
5.AST, ALT: <100IU/L
6.Serum creatinine: <1.5mg/dL
8)Patient with starting the treatment within 8 weeks after operation.
9)Written informed consent.
Key exclusion criteria
1)Active synchronous or metachronous malignancy carcinoma in situ.
2)Severe postoperative complications.
3)Severe complication.
4)Severe diarrhea.
5)Severe infectious disease.
6)Medical history of severe anaphylaxis or allergia to any drug.
7)Undergoing treatment with fluorocytosine.
8)Pregnant or lactating woman at any time during study. Men of the fertility hope.
9)Severe mental disorder.
10)Patients judged inappropriate for the study by their physicians.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Hata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL
06-6879-3251
thata@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL
06-6879-3251
Homepage URL
muemura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Study Group of Osaka (MCSGO), 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
Osaka University Clinical Research Review Committee
Address
2-15 Yamadaoka, Suita, Osaka 565-0871,Japan
Tel
06-6879-3251
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2011 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33604941/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33604941/
Number of participants that the trial has enrolled
386
Results
In total, 386 patients were enrolled between July 28, 2011, and September 27, 2013. The 3-year disease-free survival rates of group A (n = 194) and B (n = 192) were 79.4% and 81.4% , respectively.
The most common grade 3/4 adverse events in group A and B were diarrhea (3.9% vs. 7.3%), neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue (1.1% vs. 2.3%).
Results date posted
| 2021 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
stage II/III colorectal cancer in an adjuvant setting
Participant flow
a multicenter randomized trial to assess the noninferiority
of a twice-daily compared with a three-times-daily UFT/LV regimen for stage II/III colorectal cancer in an adjuvant setting
Adverse events
The most common grade 3/4 adverse
events in group A and B were diarrhea (3.9% vs. 7.3%),
neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue
(1.1% vs. 2.3%).
Outcome measures
The 3-year disease-free
survival rates of group A (n = 194) and B (n = 192) were
79.4% and 81.4% , respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2011 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006615
