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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032865
Receipt No. 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

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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
Email 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
Email yukimizu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037473

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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