UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015339
Receipt number R000017812
Scientific Title Early tumor shrinkage of Cetuximab and mFOLFOX6 in RAS-wild type unresectable metastatic colorectal cancer.
Date of disclosure of the study information 2014/10/03
Last modified on 2019/04/08 12:56:40

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Basic information

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

Condition

RAS-wild type colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

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


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kyoto University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

京都大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name