UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009083 |
|---|---|
| Receipt number | R000010657 |
| Scientific Title | Phase II study of S-1, leucovorin plus bevacizumab in refractory colorectal cancer |
| Date of disclosure of the study information | 2012/10/11 |
| Last modified on | 2015/12/19 18:34:52 |
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Basic information
Public title
Phase II study of S-1, leucovorin plus bevacizumab in refractory colorectal cancer
Acronym
Phase II study of S-1, leucovorin plus bevacizumab in refractory colorectal cancer
Scientific Title
Phase II study of S-1, leucovorin plus bevacizumab in refractory colorectal cancer
Scientific Title:Acronym
Phase II study of S-1, leucovorin plus bevacizumab in refractory colorectal cancer
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 safety and efficacy of oral S-1, leucovorin plus bevacizumab therapy in refractory metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate assessed by independent review committee
Key secondary outcomes
Disease control rate assessed by investigator, response rate, overall survival, progression free survival, toxicity, QOL
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
Oral S-1, leucovorin plus bevacizumab therapy
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) Histopathologically confirmed, unresectable colorectal adenocarcinoma
(2) Failed prior 5FU, oxaliplatin, irinotecan, bevacizumab and anti-EGFR antibody if KRAS wild type
(3) Measurable disease (RECIST ver.1.1)
(4) ECOG performance status 0-2
(5) Age of 20 years or older.
(6) No prior therapy with S-1
(7) Adequate organ function
(8) Written informed concent
Key exclusion criteria
(1) Patient with symptomatic brain metastases
(2) Massive pleural or paricardial effusion, ascites that required drainage
(3) Severe proteinuria
(4) Severe comorbidity
(5) Pregnant or possibly pregnant, and nursing women
(6) Other conditions not suitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Muro |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Yamaguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
TEL
052-762-6111
Homepage URL
Sponsor or person
Institute
Aichi Cancer Center Hospital, Department of Clinical Oncology
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital, Department of Clinical Oncology
Organization
Division
Category of Funding Organization
Local Government
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
| 2012 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2012 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
| 2012 | Year | 10 | Month | 11 | Day |
Last modified on
| 2015 | 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=R000010657
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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