UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004197
Receipt number R000005044
Scientific Title Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Date of disclosure of the study information 2010/09/13
Last modified on 2016/11/24 13:12:21

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Basic information

Public title

Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Acronym

JACCRO CC-05 study

Scientific Title

Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Scientific Title:Acronym

JACCRO CC-05 study

Region

Japan


Condition

Condition

Metastatic colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of cetuximab + FOLFOX as first line in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Overall Survival
Progression Free Survival
Safety
Best response; % change at baseline


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

mFOLFOX6+cetuximab
Cetuximab loading dose 400mg/sqm,250 mgsqm/week
L-OHP 85 mg/sqm/biweekly
Levofolinate 200 mg/sqm/biweekly
5-FU bolus 400 mg/sqm/biweekly
5-FU continuous 2,400 mg/sqm/biweekly

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients with histologically proven colorectal cancer
2.Metastatic colorectal cancer with EGFR expressed
3.KRAS wild type in codon 12, 13
4.Presence of measurable lesion (RECIST Ver.1.1)
5.no prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors
6.ECOG Performance Status(PS) 0-1
7.Age between 20 to 79 years
8.Life expectancy of more than 3 months
9.Patiens have enough organ function for study treatment
10.Written informed consent

Key exclusion criteria

1.Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
2.Symptomatic brain metastases
3.Severe infectious disease
4.Interstitial lung disease or pulmonary fibrosis
5.Comorbidity or history of heart failure
6.Sensory alteration or paresthesia interfering with function
7.Large quantity of pleural, abdominal or cardiac effusion
8.Severe comorbidity (renal failure, liver failure, hypertension, etc)
9.Prior radiotherapy for primary and metastases tumors
10.Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
11.History of severe allergy
12.History of allergy for L-OHP and other platinating agent
13.Prior treatment of cetuximab or L-OHP
14.Any other cases who are regarded as inadequate for study enrollment by investigators

Target sample size

54


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Wataru Ichikawa

Organization

National Defense Medical College Hospital

Division name

Department of Clinical Oncology

Zip code


Address

3-2 Namiki, Tokorozawa, Saitama, Japan, 359-8513

TEL

04-2995-1211

Email

wataru@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Wataru Ichikawa

Organization

National Defense Medical College Hospital

Division name

Department of Clinical Oncology

Zip code


Address

3-2 Namiki, Tokorozawa, Saitama, Japan, 359-8513

TEL

04-2995-1211

Homepage URL


Email

wataru@ndmc.ac.jp


Sponsor or person

Institute

Japan Clinical Cancer Research Organization

Institute

Department

Personal name



Funding Source

Organization

Japan Clinical Cancer Research Organization

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://link.springer.com/article/10.1007/s11523-016-0445-6

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

Completed

Date of protocol fixation

2010 Year 07 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 13 Day

Last modified on

2016 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005044


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name