UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006911 |
|---|---|
| Receipt number | R000008139 |
| Scientific Title | Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11 |
| Date of disclosure of the study information | 2011/12/19 |
| Last modified on | 2011/12/19 22:57:21 |
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Basic information
Public title
Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
Acronym
Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
Scientific Title
Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
Scientific Title:Acronym
Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Bevacizumab with SOX and Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival (PFS)
Key secondary outcomes
Response rate (RR)
Time to treatment failure (TTF)
Overall Survival (OS)
Safety profile
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SOX+Bevacizumab
Bevacizumab 7.5mg/kg/triweekly
L-OHP 130 mg/m2/triweekly
TS-1 80,100,120 mg/twice/day 1-14, following one week off
Interventions/Control_2
XELOX+Bevacizumab
Bevacizumab 7.5mg/kg/triweekly
L-OHP 130 mg/m2/triweekly
Capecitabine 2400-4200 mg/twice/day 1-14, following one week off
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) Patients with histologically proven colorectal cancer
(2) Metastatic colorectal cancer
(3) Age over 20
(4) ECOG Performance Status (PS) 0-1
(5) A measurable or evaluable lesion is confirmed with objective documents such as CT, MRI and the X-ray check within 30th before registration (a measurable lesions in RECIST criteria is unnecessary)
(6) Metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
(7) Ability of oral intake
(8) Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration
(9) Life expectancy of more than 3 months
(10) Written informed consent
Key exclusion criteria
(1) History of severe allergy
(2) Pregnant or lactating women or women of childbearing potential
(3) Severe infectious disease
(4) Serious complication (e.g. interstitial pneumonia or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
(5) Comorbidity or history of heart failure
(6) Peptic ulcers
(7) Peripheral neuropathy
(8) Severe diarrhea
(9) Massive ascites or pleural effusion requiring treatment
(10) Metastasis to the CNS
(11) Current or previous (within the last 6 months) history of GI perforation
(12) Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia or hemoptysis (=> 2.5ml)
(13) Any surgical treatments within 28 days
(14) Evidence of bleeding diathesis or coagulopathy
(15) Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
(16) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(17) Under coutinuous steroid administration
(18) Administration contraindication of L-OHP, Bevacizumab, S-1 or Capecitabine
(19) Presence of severe colorectal stricture
(20) Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Sakai |
Organization
Tsuchiura kyodo general hospital
Division name
Department of Gastroenterology
Zip code
Address
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Masuishi |
Organization
Tsuchiura kyodo general hospital
Division name
Department of Gastroenterology
Zip code
Address
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tsuchiura kyodo general hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2011 | 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=R000008139
