UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003935 |
|---|---|
| Receipt number | R000004731 |
| Scientific Title | To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2022/10/11 16:18:17 |
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Basic information
Public title
To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Acronym
To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Scientific Title
To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Scientific Title:Acronym
To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the combination of XELOX+Bevacizumab in the patients with unresectable advanced recurrent coloreatal cancer who have first-line chemotherapy including treatment failure or refractory (without oxlplatin based regimen) as second-line chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression Free Survival
Overall survival, 1-year survival rate
Disease control rate
Response time
Safety
Overall survival from first line Second progression free survival (Progression Free Survival from first line)Case who has bevacizumab treatment in Registered patient,
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
XELOX+ 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)Disease progression(PD)
or difficult to continue for other reason after chemotherapy with Oxaliplatin containing regimen
2)Histological confirmation of colorectal cancer.
3) Advanced or recurrent colorectal cancer that is not amenable to curative resection.
4) Age: 20 years old or more.
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
7) Life expectancy greater than or equal to 3 months
8) Vital organ functions (listed below) are preserved within 14 days prior to entry
9) Patient of possible oral ingestion
10) Patient who doesn't have cerebral metastasis
11)Written informed consent
12) Other conditions suitable for this study
Key exclusion criteria
1) Treatment with tegafur gimestat otastat potassium Within 7 days
2)History of the serious hypersensitivity for Fluorouracil , Levofolinate calcium,platinum or bevacizumab
3) Active multiple Primary cancer within 5 years
4) History of adverse events related to DPD loss
5) Uncontrolled diarrhea
6) Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
7)Complication of cerebrovascular disease or symptoms within 1 years
8) Administering antithrombotic drug within 10 days before enrollment
9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS)
10)Evidence of bleeding diathesis or
coagulopathy
11)Symptom of colorectal obstruction
12)uncontrolled complication of peptic ulcer
13)Current or previous (within the last 1 year) history of GI perforation
14)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry
15)Uncontrolled Hypertension
16)Uncontrolled Infection
17)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
18)Man who doesn't practice birth control
19)Treatment history of Oxlplatin
20)Other conditions not suitable for this study
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Mutsumi |
| Middle name | |
| Last name | Hukunaga |
Organization
Sakai Municipal Hospital
Division name
Surgery
Zip code
590-0064
Address
1-1-1 minamiyasuityo sakai-ku sakai city Osaka
TEL
072-221-1700
fukunaga-m@sakai-hospital.jp
Public contact
Name of contact person
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Mizushima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL
06-6879-3251
Homepage URL
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka University
Address
2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel
06-6879-3251
tmizushima@gesurg.med.osaka-u.ac.jp
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
| 2010 | Year | 08 | 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
| 2010 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004731
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/07/06 | 治癒切除不能・進行再発大腸癌における2次治療としてのXELOX+ベバシズマブ併用療法に関する有効性の検討.zip |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
