UMIN-CTR Clinical Trial

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

Metastatic colorectal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery
Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Status of therapy
Safety
Efficacy

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Public Health Research Foundation

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

No

Address

No

Tel

No

Email

No

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

02

Month

13

Day

URL releasing protocol

https://www.csp.or.jp/cspor/company/

Publication of results

Partially published

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

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 related information

-

Registered date

2012

Year

02

Month

13

Day

Last modified on

2020

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008581