UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of pharmacokinetics and pharmacodynamics for capecitabine during new chemotherapy regimen by bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer
Title of the study (Brief title)	Analysis of pharmacokinetics and pharmacodynamics for Capecitabine during new chemotherapy regimen
Region	Japan

Condition
Condition	unresectable colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Confirmation for safety and efficacy of new chemotherapy regimen for Bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer by analysis of pharmacokinetics and pharmacodynamics for capecitabine.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confirmation for PK/PD analysis of capecitabine
Key secondary outcomes

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	Measurement ofcapecitabin metabolism during XELOX+BV 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.informed consent 2.more than 20 yeras old 3.ECOG Performance Status 0-2 4.survival more than 3 months 5.histopathological colorectal cancer 6.measurable lesion as RECIST Ver 1.1 7.first or first recurrent colorectal cancer 8.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 and ALP less than 100IU/L (with liber metastasis less than 200IU/L) , Cr less than 1.5mg/dL, urinary protein 1+
Key exclusion criteria	1.Treatment for ascites and thoracic effusion is needed. 2.There is brain tumor or brain metastasis. 3.Untreated double cancer within 5 years 4.There is cerebrovascular disease 5.surgery within 4 weeks 6.surgery for study 7.use of drug effected for blood coagulation system 8.Bleeding tendency 9.Uncontrorable peptic ulcer 10.gastrointestinal perforation within 6 months 11.untreated fructure 12.renal failure 13.Uncontrorable hypertension 14.Uncontrorable diabetes meritus 15.heart disease 16.hypersensitivity for fluorouracil and platinum 17.DPD defect 18.Uncontrorable diarrhea 19.interstitial pneumonia or pulmonary fibrosis 20.organ transplant needed immunosuppressant drug 21.Uncontrorable infectious disease 22.similarterm for BV treatment 23.difficult for oral intake
Target sample size	10

Research contact person
Name of lead principal investigator	Tsukasa Hotta
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	hotta@wakayama-med.ac.jp

Public contact
Name of contact person	Tsukasa Hotta
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	hotta@wakayama-med.ac.jp

Sponsor
Institute	Tsukasa Hotta
Institute
Department

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)

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 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 24 Day
Anticipated trial start date	2014 Year 02 Month 01 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 31 Day
Last modified on	2019 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015215