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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007275
Receipt No. R000008581
Scientific Title Observational study of first-line therapy including cetuximab in patients with metastatic colorectal cancer
Date of disclosure of the study information 2012/02/13
Last modified on 2020/04/01

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Basic information
Public title Observational study of first-line therapy including cetuximab in patients with metastatic colorectal cancer
Acronym Cetuximab observational study as first-line therapy (CORAL study)
Scientific Title Observational study of first-line therapy including cetuximab in patients with metastatic colorectal cancer
Scientific Title:Acronym Cetuximab observational study as first-line therapy (CORAL study)
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the status in relation to historical/reference data of first-line therapy including cetuximab in patients with metastatic colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Status of therapy
Safety
Efficacy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with metastatic colorectal cancer before registration of this study
(2)Patients with ECOG PS 0-2
(3)Patients with received treatment as 1st-line therapy including cetuximab
Key exclusion criteria (1)Patients with double cancers affecting prognosis
(2)Patients received neo-adjuvant. chemotherapy for resectable liver metastasis
(3)Patients judged ineligible to participate in this study by an attending physician
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Michio / Kei
Middle name
Last name Itabashi / Muro
Organization Tokyo Women's Medical University/
Aich Cancer Center Hospital
Division name Department of Surgery2/Department of Clinical Oncology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo162-8666, Japan/1-1 Kanakoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 03-3353-8111
Email no@mail

Public contact
Name of contact person
1st name Akira
Middle name
Last name Yamao
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Clinical Research
Zip code 169-0051
Address Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan
TEL 03-5287-2636
Homepage URL http://www.csp.or.jp/
Email cspor-office@csp.or.jp

Sponsor
Institute Public Health Research Foundation
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization No
Address No
Tel No
Email No

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
2012 Year 02 Month 13 Day

Related information
URL releasing protocol https://www.csp.or.jp/cspor/company/
Publication of results Partially published

Result
URL related to results and publications https://academic.oup.com/jjco/article/49/4/339/5310117?searchresult=1
Number of participants that the trial has enrolled 578
Results
Of 578 patients, 562 were classified into G1 (n = 165), G2 (n = 224), or G3 (n = 173). The resection rate of any site was higher in G1 (57.0%) than in G2 (11.2%) and G3 (11.6%). G1, G2, and G3 showed median overall survivals (95% confidence interval) of 45.9 (38.1-not available), 16.7 (14.5-18.8), and 30.6 (23.2-34.8) months, respectively (P < 0.0001). The common tumor-related symptoms in G2 were pain, fatigue, and anorexia, from which 31.7%, 22.2%, and 14.8% of the patients suffered at baseline.
Results date posted
2019 Year 08 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This prospective observational study included patients with previously untreated mCRC from 158 centers in Japan who started first-line cetuximab-containing chemotherapy from January 2012 to June 2013 and were followed for up to 3 years. 
Participant flow
During the period from January 2012 to June 2013, 578 mCRC patients were enrolled in the study from 158 centers in Japan; of those, 562 patients from 152 centers met the inclusion criteria of the study. Out of these 562 patients, KRAS wild-type 538 (96%), KRAS mutation type 14 (2%), not measured 5 (1%) and unknown 5 (1%) were diagnosed with KRAS wild-type and mutation tumors, respectively (Table 1). There were 165 (29%), 224 (40%), and 173 (31%) patients classified into Groups 1, 2, and 3, respectively, in accordance with the ESMO consensus guidelines. Background characteristics are shown in Table 2. The proportions of patients with ECOG PS > 1, high level of LDH, and present primary tumor location were higher in Group 2 (45%, 63%, and 54%) than in Group 1 (21%, 40%, and 29%) or 3 (20%, 38%, and 14%). The demographics with regard to gender, age, and KRAS status were well balanced among the three groups.
Adverse events
Skin reactions (CTCAE Grade 1<) were frequently observed in the study and were considered to be cetuximab-related adverse events, including acneiform rash, xeroderma, paronychia, pruritus, fissures/skin ulcer, and hair disorder. Acneiform rash was observed with the highest incidence of 68.6% of the patients at 8 weeks after cetuximab treatment was started, and the incidence gradually decreased to 50.2% at 24 weeks and to 18.2% at 1.5 years (Figure 4). Other skin reactions developed gradually with a peak at 16 weeks, later than that of acneiform rash, and then decreased in frequency (Figure 4). The incidence of hypomagnesemia increased gradually to 12.7% with a peak at 1 year after treatment and then decreased to 5.1% at 1.5 years (Figure 4).
Outcome measures
This observational study suggests that cetuximab-containing regimens as the first-line treatment are effective and tolerable in Japanese patients with mCRC, and that the classification of the ESMO Guidelines 2012 is applicable to Japanese patients.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 11 Month 15 Day
Date of IRB
2011 Year 12 Month 13 Day
Anticipated trial start date
2011 Year 12 Month 26 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information -

Management information
Registered date
2012 Year 02 Month 13 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008581

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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