UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009280 |
|---|---|
| Receipt number | R000010902 |
| Scientific Title | A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy |
| Date of disclosure of the study information | 2012/11/07 |
| Last modified on | 2019/12/19 15:47:22 |
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Basic information
Public title
A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Acronym
JSWOG C3
Scientific Title
A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Scientific Title:Acronym
JSWOG C3
Region
| Japan |
Condition
Condition
advanced and/or recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of XELIRI plus bevacizumab in advanced colorectal cancer 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
progression free survival and safety
Key secondary outcomes
overall survival,time to progression, and safety,Response rate,Dose Intensity,and Analysis of the safety and efficacy of CPT-11-containing regimens based on genetic polymorphisms UGT1As
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
XELIRI plus bevacizumab therapy
Capecitabine: 2000 mg/m2 day1 to 8
CPT11 150mg/m2 day1
Bevacizumab: 10mg/kg day 1
The treatment is repeated every two weeks until disease progression or severe toxicity.
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 after the explanation of the content of the examination
(2) Age of 20 years or elder
(3) ECOG performance status of 0 and 1
(4) Life expectancy more than 3 months
(5) Histopathologically confirmed colorectal cancer
(6) Measurable or evaluable disease (RECIST ver.1.1)
(7) Metastatic colorectal cancer which has prior therapy of Oxalipalatin based chemotherapy
(8) Adequate organ functions
Key exclusion criteria
(1) Massive pleural effusion or ascites that required drainage
(2) Severe liver disease
(3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
(4) Severe renal failure
(5) Metastases to the CNS
(6) History of active double cancer within 5 years
(7) Complication of cerebrovascular disease or symptoms within 1 year
(8) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week
(9) Radiation therapy within 4 weeks before enrollment
(10) Administering antithrombotic drug within 10 days before enrollment
(11) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day)
(12) A bleeding tendency, coagulation disorder or abnormal coagulation factor
(13) Uncontrollable peptic ulcer
(14) History of gastrointestinal perforation within 1 year.
(15) Patient with untreated traumatic bone fracture
(16) Uncontrollable hypertension
(17) Serious heart disease
(18) History of severe allergy with 5-FU
(19) Uncontrollable diarrhea
(20) Interstitial pneumonitis
(21) Inability of oral Agent intake
(22) Requiring novel immunosuppressant and steroid
(23) Receiving atazanavir sulfate
(24) Severe infection disease
(25) Treatment history of CPT-11
(26) Other conditions not suitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Hazama |
Organization
Yamaguchi University
Division name
Digestive surgery and surgical oncology
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL
+81-836-22-2264
hazama@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Hazama |
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
Digestive surgery and surgical oncology
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL
+81-836-22-2264
Homepage URL
hazama@yamaguchi-u.ac.jp
Sponsor or person
Institute
NPO Japan Southwest Oncology Research Support Organization(JSWOG)
Institute
Department
Personal name
Funding Source
Organization
NPO Japan Southwest Oncology Research Support Organization(JSWOG)
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
Yamaguchi University
Address
1-1-1 Minamikogushi , Ube, 755-8505, Japan
Tel
0836-22-2428
clin_res@yamaguchi-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
| 2012 | Year | 11 | Month | 07 | 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
51
Results
51 patients were enrolled in this study. Median PFS was 5.5 months, and median OS was 13.5 months. The RR was 14.6%, and the DCR was 66.7%. Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand-foot syndrome. In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.
Results date posted
| 2019 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 29 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2012 | Year | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010902
