UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032865 |
|---|---|
| Receipt number | R000037473 |
| Scientific Title | A randomized controlled trial comparing capecitabine 5-days-on/2-days-off regimen with conventional regimen in stage II and III colorectal cancer. |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2018/12/05 15:42:49 |
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Basic information
Public title
A randomized controlled trial comparing capecitabine 5-days-on/2-days-off regimen with conventional regimen in stage II and III colorectal cancer.
Acronym
A randomized clinical trial of capecitabine 5-days-on/2-days-off regimen or conventional regimen in colorectal cancer.
Scientific Title
A randomized controlled trial comparing capecitabine 5-days-on/2-days-off regimen with conventional regimen in stage II and III colorectal cancer.
Scientific Title:Acronym
A randomized clinical trial of capecitabine 5-days-on/2-days-off regimen or conventional regimen in colorectal cancer.
Region
| Japan |
Condition
Condition
StageII(high risk) and stageIII resectable colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility 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
feasibility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Capecitabine 5-days on/ 2-days off schedule
Interventions/Control_2
Capecitabine conventional schedule
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.Histopathological diagnosis of colorectal cancer
2.Postoperative adjuvant chemotherapy is scheduled after colorectal cancer resection in Stage II and III.
3. Chemotherapy of capecitabine is scheduled as postoperative adjuvant chemotherapy.
4.Age:20-80 years old
5.ECOG Performance Status 0-1
6. i)WBC more than 3000/mm3,
ii) neutrophil more than 1500/mm3,
iii) Platelet more than 10x10^4/mm3,
iv) Hb more than 9g/dL,
v) TBil less than 1.5mg/dL,
vi) AST and ALT less than 100IU/L
vii) Cr less than 1.5mg/dL,
7.chemotherapy has not been administered for the target disease
8.informed consent
Key exclusion criteria
1. duplicated active cancer
2. history of severe drug hypersensitivity
3. clinically problematic infection
4. it is judged that registration in this study is difficult due to clinically problematic mental / neurological diseases
5. any of the following complications
i) diabetes with poor control
ii) hypertension with poor control
iii) interstitial pneumonia or pulmonary fibrosis
iv) intestinal palsy or intestinal obstruction
v) clinically problematic heart disease
6. already undergoing other chemotherapy before and after surgery
7. temporary ileostomy/colostomy closure is scheduled and the administration period of continuous 24 weeks is interrupted for a long time
(8) Other cases that the doctor in charge judged unsuitable for safely carrying out this study.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
yukimizu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Mizumoto |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
yukimizu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2018 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037473
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