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 UMIN000006070
Receipt No. R000007183
Scientific Title A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.
Date of disclosure of the study information 2011/07/29
Last modified on 2017/04/30

* 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 A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.
Acronym A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.(KSCC1101)
Scientific Title A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.
Scientific Title:Acronym A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.(KSCC1101)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficacy and the safety of tri-weekly xeliri with bevacizumab as a first line chemotherapy for the patients with unresectable or recurrent colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival
Time to treatment failure
Time to failure of strategy
Overall survival
Safety
Investigation of Nausea and vomiting
Quality of life

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tri-weekly XELIRI+ bevacizumab
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.written informed consent
2.appropriate for the study at the physician's assessment
3. histological confirmation of colorectal cancer.
4.no prior chemotherapy for the patients with unresectable or recurrent colorectal cancer
5.aged 20<= years.
6.ecog performance status of 0-1.
7.at least one measurable lesion based on the recist criterion. (within 28 days before registration)
8.life expectancy at least 3 months.
9.required baseline laboratory parameters (within 14 days before registration):
wbc more than 3000 and wbc less than 12000/mm3
neu more than 1,500/ mm3
plt more than 100,000/ mm3
hb more than 9.0g/dl
t-bil less than 1.5mg/dl
ast and alt <= 100IU/l
(200iu/i in case of liver metastasis)
cre less than 1.5mg/dl
urinary protein less than grade1 (+1 or 0.15-1.0g/24h)
patients with ugt1a1 genotype wild type and *6,*28 heterozygote
Key exclusion criteria 1.co-mobility, such as infection, heart failure, history of cardiac infarction, liver cirrhosis, viral hepatitis type b , jaundice, kidney failure, uncontrolled hypertension, diabetes, interstitial lung disease, lung fibrosis, pulmonary emphysema.
2.coelomic fluid which need therapy( pleural effusion, abdominal dropsy, pericardial fluid)
3.history of the severe hypersensitivity
4.active other malignancies.
5.history of mental disorder, central nerve disorder, cerebral vascular disorder.
6. prior radiotherapy for primary and metastases tumors
7.brain metastasis
8.evidence of bleeding diathesis, intestinal paralysis , ileus, peptic ulcer, traumatic bone fracture
9.watery stools or grade 2 or more diarrhea
10. requiring anti-thrombogenic therapy to prevent thrombosis
11.requiring immunosuppressant and steroid drug
12. receiving atazanavir sulfate
13.pregnant or lactating woman
14. treatment history of irinotecan
15.not appropriate for the study at the physician's assessment
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Sakai
Organization Saiseikai Kumamoto Hospital
Division name Department of Clinical oncology
Zip code
Address 5-3-1, Chikami, Kumamoto City, 861-4193, Japan
TEL 092-631-2920
Email kscc2@cres-kyushu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name KSCC Secretariat
Organization clinical research support center Kyushu
Division name KSCC Secretariat
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
TEL 092-631-2920
Homepage URL
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
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 九州大学病院(福岡県)、公立学校共済組合九州中央病院(福岡県)、済生会福岡総合病院(福岡県)、済生会八幡総合病院(福岡県)、新日鐵八幡記念病院(福岡県)、社会保険田川病院(福岡県)、社会保険仲原病院(福岡県)、社会保険久留米第一病院(福岡県)、大牟田市立病院(福岡県)、宗像医師会病院(福岡県)、福岡市民病院(福岡県)、福岡大学筑紫病院(福岡県)、佐世保市立総合病院(長崎県)、長崎大学病院(長崎県)、春回会井上病院、長崎百合野病院(長崎県)、済生会熊本病院(熊本県)、熊本赤十字病院(熊本県)、熊本大学病院(熊本県)、健康保険人吉総合病院(熊本県)、健康保険八代総合病院(熊本県)、熊本中央病院(熊本県)、大分赤十字病院(大分県)、国立病院機構大分医療センター(大分県)、国立病院機構別府医療センター(大分県)、中津市立中津市民病院(大分県)、国立病院機構南九州病院(鹿児島県)、今給黎総合病院(鹿児島県)、潤愛会鮫島病院(鹿児島県)、鹿児島大学病院(鹿児島県)、鹿児島共済会南風病院(鹿児島県)、鹿児島県立薩南病院(鹿児島県)、浦添総合病院(沖縄県)、中頭病院(沖縄県)、南部医療センター・こども医療センター(沖縄県)、松山赤十字病院(愛媛県)、広島赤十字・原爆病院(広島県)、高知医療センター(高知県)、神戸市立医療センター 中央市民病院(兵庫県)、川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 12 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
2011 Year 07 Month 29 Day
Last modified on
2017 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007183

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.