UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000004011
Receipt No. R000004820
Scientific Title Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study
Date of disclosure of the study information 2010/08/20
Last modified on 2020/08/17 (Ver. 6)

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Basic information
Public title Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study
Acronym SOBIC study
Scientific Title Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study
Scientific Title:Acronym SOBIC study
Region
Japan

Condition
Condition Metastatic Colorectal Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of SOX plus bevacizumab as first line therapy followed by IRIS plus cetuximab ( K-ras mutations : IRIS plus bevacizumab or IRIS ) in patients with metastatic colorectal carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Second PFS (progression-free survival)
Key secondary outcomes Receive rate of second line therapy, Overall survival, rate of KRAS mutation / wild type.
Each evaluation of the first and second line respectively: response rate (RR), PFS, conversion rate of nonresectable to resectable and R0 resection ratio (R0-R), safety profile.

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 1st line
SOX+BV
2nd line
IRIS+Cmab
IRIS+Bmab
IRIS
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1)Patients with histologically proven colorectal cancer
(2)Unresectable or recurrent colorectal camcer
(3)Age >= 20 and =< 80
(4) ECOG performance status of 0,1.
(5) Unresectable primary tumor or with one or more unresectable metatatic tumor
Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) within 30 days before registration.
(6)No prior chemotherapy or first recurrence with no chemotherapy for recurrent lesion.(without receiving adjuvant chemotherapy by 5FU only)
(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
Key exclusion criteria (1) History of the serious hypersensitivity for Fluorouracil, oxaliplatin or bevacizumab
(2) Pregnant or lactating women or women of childbearing potential.
(3) Severe infectious disease
(4) Serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
(5) Comorbidity or history of heart failure
(6) Peptic ulcers
(7) Severe dysesthesia or sensory abnormality with functional disorder
(8) Severe diarrhea
(9) Massive pleural effusion or ascites.
(10) Obstruction or disorder on digestive tract due to peritoneal metastasis
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Naohiro
Middle name
Last name Tomita
Organization Hyogo College of Medicine
Division name Department of Surgery
Zip code 663-8501
Address 1-1, Mukogawa-Cho, Nishinomiya, Hyogo
TEL 0798-45-6370
Email ntomita@hyo-med.ac.jp

Public contact
Name of contact person
1st name Masafumi
Middle name
Last name Noda
Organization Hyogo College of Medicine
Division name Department of Surgery
Zip code 663-8501
Address 1-1, Mukogawa-Cho, Nishinomiya, Hyogo
TEL 0798-45-6370
Homepage URL
Email ntomita@hyo-med.ac.jp

Sponsor
Institute Hyogo Colorectal Cancer Study 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 Hyogo College of Medicine
Address 1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
Tel 0798-45-6370
Email ntomita@hyo-med.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
2010 Year 08 Month 20 Day

Related information
URL releasing protocol none
Publication of results Published

Result
URL related to results and publications International Journal of Clinical Oncology, 25(7), 1285-1290
Number of participants that the trial has enrolled 52
Results 
The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7  35.2). The response rate after first- and second-line chemotherapy was 46.7% and 20%, respectively. The median overall survival was 35.2 months (95% CI: 27.8 to not reached). The main grade 3,4 adverse events were sensory neuropathy (18%), fatigue (10%), and anorexia (8%). There were no treatment-related deaths among patients administered the first-line and second-line regimens.
Results date posted
2020 Year 08 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 07 Month 02 Day
Baseline Characteristics 
Total No. of patients : 50
Gender : male 30 / female 20
Median age : 65 (35-77)
Tumor location : colon 30 / rectum 20
Complication : + 9 / - 39 / unknown 2
KRAS staus : mutaion 20 / wild 20 / unknown 10
Participant flow 
From May 2010 through March 2013, 52 patients from 10 institutions in the HCCSG were enrolled. Two patients, 1 who withdrew consent and 1 with no measurable lesion, were excluded from analysis. This, 50 patients were included in the efficacy analysis. All these 50 patients received first-line chemotherapy (SOX + Bmab). Second-line therapy (IRIS + Cmab, IRIS + Bmab, or IRIS) was administered to 20 patients (20%). Among the 20 patients, 12 patients received IRIS + Cmab and 8 patients received IRIS + Bmab.
Adverse events 
The main grade 3,4 adverse events were sensory neuropathy (18%), fatigue (10%), and anorexia (8%). There were no treatment-related deaths among patients administered the first-line and second-line regimens.
Outcome measures 
The primary end-point of this study was the second progression-free survival (PFS), defined as the period from the date of enrollment to the date of either disease progression or death from any cause after second-line chemotherapy whichever came first. Secondary end-points were overall survival (OS), response rate (RR) after first- and second-line chemotherapy, the R0 resection rate (R0-rate), and adverse events.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 04 Month 23 Day
Date of IRB
2010 Year 07 Month 12 Day
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2016 Year 02 Month 22 Day
Date of closure to data entry
2016 Year 02 Month 22 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 06 Day
Last modified on
2020 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004820