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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006706
Receipt No. 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

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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
Email 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
Email muemura@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Institute
Department

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
Email 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
URL(English) 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


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