UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial comparing capecitabine 5-days-on/2-days-off regimen with conventional regimen in stage II and III colorectal cancer.
Title of the study (Brief title)	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	Hiroki Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	yukimizu@wakayama-med.ac.jp

Public contact
Name of contact person	Yuki Mizumoto
Organization	Wakayama Medical University
Division name	Second Department of Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000037473