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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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