UMIN-CTR Clinical Trial

Public title

Early tumor shrinkage of Cetuximab and mFOLFOX6 in RAS-wild type unresectable metastatic colorectal cancer.

Acronym

Elite Trial

Scientific Title

Early tumor shrinkage of Cetuximab and mFOLFOX6 in RAS-wild type unresectable metastatic colorectal cancer.

Scientific Title:Acronym

Elite Trial

Region

Japan

Condition

RAS-wild type colorectal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery
Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the ETS(Early Tumo Shrinkage) rate and safety of biweekly Cetuximab and mFOLFOX6 in RAS-wild type unresectable metastatic colorectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

ETS(Early Tumor Shrinkage) rate

Key secondary outcomes

PFS:Progression free survival
TTF:Time to treatment failure
Adverse events
ORR: overall response rate
Pathological response rate
OS:Overall survival
Treatment completion rate
RDI: relative dose intensity
Resection rates of metastatic sites
R0 rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Weekly Cetuximab+mFOLFOX6
Cetuximab 400mg/m2/ initial
250mg/m2/ qw
Oxaliplatin 85mg/m2/ qw
l-LV 200mg/m2/ qw
5FU-bols 400mg/m2/ qw
5FU-infusional 2,400mg/m2/ qw

OR

Biweekly Cetuximab+mFOLFOX6
Cetuximab 500mg/m2/ q2w
Oxaliplatin 85mg/m2/ q2w
l-LV 200mg/m2/ q2w
5FU-bols 400mg/m2/ q2w
5FU-infusional 2,400mg/m2/ q2w

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum and
inoperable metastatic disease
2.KRAS Exon2,3,4 AND NRAS Exon2,3,4 WT
3.No Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
4.Presence of a measurable index lesion(RECIST v1.1)
5.20 years of age and older
6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 at study entry
7.Adequate organ functions
1)WBC;3,000-12,000/mm3
2)ANC: greater than or equql to 1,500/mm3
3)Platelet: greater than or equql to 100,000/mm3
4)Hb: greater than or equql to 9.0g/dl
5)T-bil:less than or equal to 1.5 times the upper limit of normal (ULN)
6)aspartate transaminase (AST) or alanine transaminase (ALT) levels less than or equal to 2.5 times the ULN
7)serum creatinine level less than or equal to 1.5 times the ULN
8.Life expectancy of at least 3 months
9.Provided signed written informed consent.

Key exclusion criteria

1.Severe infection
2.Prior hypersensitivity reaction to drugs useing in this trial
3.Dementia, altered mental status, or any psychiatric condition
4.Severe body fruid (ascites,pleural effusion.pericardiac effsion)
5.Severe stenotic primary lesion
6.Recieved radiotherapy to target lesion
7.Medical conditions that compromise the patient's ability to give informed consent or to complete the protocol
8.Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab and so on
9.Active other malignant disease
10.Symptomatic brain metastasis
11.Uncontroled severe diarrhea
12.Pregnancy or lactation
13.Women and partners of women of childbearing potential cannot agree to use adequate contraception

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shigemi Matsumoto

Organization

Kyoto University Hospital

Division name

Department of Clinical Oncology

Zip code

Address

54 Syogoinkawara-cho, Sakyo-ku, Kyoto

TEL

075-751-4349

Email

oncolpgx@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shigemi Matsumoto

Organization

Kyoto University Hospital

Division name

Department of Clinical Oncology

Zip code

Address

54 Syogoinkawara-cho, Sakyo-ku, Kyoto

TEL

075-751-4349

Homepage URL

Email

oncolpgx@kuhp.kyoto-u.ac.jp

Institute

Kyoto University Hospital

Institute

Department

Personal name

Organization

Kyoto University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院

Date of disclosure of the study information

2014

Year

10

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Terminated

Date of protocol fixation

2014

Year

09

Month

08

Day

Date of IRB

2014

Year

10

Month

06

Day

Anticipated trial start date

2014

Year

10

Month

14

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

10

Month

03

Day

Last modified on

2019

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017812