UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006706 |
|---|---|
| Receipt number | R000007920 |
| Scientific Title | A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type. |
| Date of disclosure of the study information | 2011/11/11 |
| Last modified on | 2021/05/25 15:54:37 |
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Basic information
Public title
A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type.
Acronym
A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type. (SOX+BC)
Scientific Title
A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type.
Scientific Title:Acronym
A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type. (SOX+BC)
Region
| Japan |
Condition
Condition
previously untreated recurrent advanced colorectal cancer with KRAS wild type
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized phase II study consisting SOX+B-mab and SOX+C-mab for evaluate the efficacy and tolerability in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Desease control rate, Progression-free survival, Overall survival, Time to treatment failure, Completion rate of treatment, R0 resection rate, Time to efficacy, Frequency and grade of adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group (SOX+B-mab)
TS-1 administered for 14 days followed by 7 days rest according to body surface area.
L-OHP is administered intravenously in 130 mg/m2 at day 1.
B-mab is administered intravenously in 7.5 mg/kg by tri-weekly.
Interventions/Control_2
B group (SOX+C-mab)
TS-1 administered for 14 days followed by 7 days rest according to body surface area.
L-OHP is administered intravenously in 130 mg/m2 at day 1.
C-mab is administered intravenously in 400 mg/m2 on day 1, then 250 mg/m2 weekly thereafter. Or C-mab is administered intravenously in 500 mg/m2 by bi-weekly.
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.Histopathological confirmation of Adenocarcinoma.
2.Untreated recurrent or advanced colorectal cancer.
3.KRAS wild type
4.Measurable disease
5.Age 20=<
6.ECOG performance status of 0 to 1
7.No prior chemotherapy
8.At least one measurable lesion based on the recist criterion. (within 30 days before registration)
9.Sufficient function of important organs
Leu : >=4,000 /mm3
Neu : >= 2,000 /mm3
Plt : >= 100,000 /mm3
hemoglobin : >= 9.0 g/dL
AST, ALT : =< 2.5xULN IU/L (5.0xULN IU/L in case of liver metastasis)
St.bil : =< 1.5 mg/dL
Ccr : >= 40 ml/min
proteinuria : =<1+
INR : =<1.5
10.Expected more than 3 months survival
11.Sufficient oral intake
12.With written informed consent
Key exclusion criteria
1.History of the severe hypersensitivity
2.Active infection and inflammation.
3.Severe complications
4.Case with the history of usage of the L-OHP
5.Patients under treatment with steroid
6.Patients under treatment with flucytosine, phenytoin or warfarin potassium
7.Symptomatic or asymptomatic but treated heart disease
8.Patients have peripheral sensory neuropathy
9.Watery stools or diarrhea
10.Patients have Active hepatitis type B
11.Massive pleural or abdominal effusion
12.Patients have gastrointestinal perforation or bleeding
13.High-grade stricture
14.High-grade peritoneal metastasis or node
15.Metastasis to CNS
16.synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
17.Pregnant or lactating woman
18.No birth-control
19.Other patients who are unfit for the study as determined by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Mizushima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
565-6879
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL
06-6879-3251
muemura@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Uemura |
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
muemura@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 Clinical Research Review Committee
Address
2-15 Yamadaoka, Suita, Osaka 565-0871,Japan
Tel
06-6879-5685
rinri@hp-crc.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
| 2011 | Year | 11 | Month | 11 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | 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
| 2011 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007920
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/07/06 | KRAS野生型の進行・再発大腸癌に対するSOX＋B-mab療法とSOX＋C-mab療法の無作為化比較第Ⅱ相試験.zip |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
