UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006070 |
|---|---|
| Receipt number | 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 18:28:28 |
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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
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
kscc2@cres-kyushu.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007183
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| Registered date | File name |
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