UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004011 |
|---|---|
| Receipt number | 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 12:56:55 |
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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
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
ntomita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Colorectal Cancer Study 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
Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
Tel
0798-45-6370
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004820
