UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012813 |
|---|---|
| Receipt number | R000014967 |
| Scientific Title | Phase II trial as new adjuvant chemotherapy regimen for capecitabine in stage II and III colorectal cancer. |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2019/01/18 16:47:34 |
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Basic information
Public title
Phase II trial as new adjuvant chemotherapy regimen for capecitabine in stage II and III colorectal cancer.
Acronym
Phase II trial as new adjuvant chemotherapy regimen for capecitabine
Scientific Title
Phase II trial as new adjuvant chemotherapy regimen for capecitabine in stage II and III colorectal cancer.
Scientific Title:Acronym
Phase II trial as new adjuvant chemotherapy regimen for capecitabine
Region
| Japan |
Condition
Condition
StageII(high risk) and stageIIIa resectable colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of new adjuvant chemotherapy regimen for capecitabine in stage II and III colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence rate of side effect
Key secondary outcomes
Disease free survival, safety, proportion of treatments completed, quality of life.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Capecitabine 5-days on/ 2-days off schedule
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.Histopathological diagnosis of stage II(high risk) and IIIa colorectal cancer
2.curable resection
3.more than 20 yeras old
4.ECOG Performance Status 0-2
5.WBC more than 3000/mm3,
neutrophil more than 1500/mm3,
Platelet more than 10x104/mm3,
Hb more than 9g/dL,
TBil less than 1.5mg/dL,
AST and ALT less than 100IU/L
Cr less than 1.5mg/dL,
6. it is possible to perform adjuvant chemotherapy within 8 weeks after tumor resection
7.informed consent
Key exclusion criteria
1.Pregnant female
2.It may be pregnant state female
3.Past history of malignant disease
4.There is uncontrolled cerebrovascular disease
5.There was serious allergy for fluorouracl related drug
6.There was allergy due to the lack of DPD
7.There is uncontrorable infection disease
8.It is difficult to intake oral food
9.Judgementof study controlled doctor
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukasa Hotta |
Organization
Wakayama Medical University,
School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
hotta@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa Hotta |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
hotta@wakayama-med.ac.jp
Sponsor or person
Institute
Tsukasa Hotta
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University,
School of Medicine
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
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 | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014967
