UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010160
Receipt No. R000011896
Scientific Title Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.
Date of disclosure of the study information 2013/04/01
Last modified on 2019/01/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.
Acronym Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX
Scientific Title Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.
Scientific Title:Acronym Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX
Region
Japan

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

Objectives
Narrative objectives1 Safety and efficacy of new chemotherapy regimen for Bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival.
Key secondary outcomes Safety, overall response rate, time to treatment failure, overall survival.

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 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 27

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
Email hotta@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukasa Hotta
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 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)

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
2013 Year 04 Month 01 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 03 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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

Other
Other related information

Management information
Registered date
2013 Year 03 Month 04 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/ctr_e/ctr_view.cgi?recptno=R000011896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.