UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004694
Receipt number R000005587
Scientific Title Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer
Date of disclosure of the study information 2010/12/10
Last modified on 2018/09/27 11:24:44

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Basic information

Public title

Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer

Acronym

N-SOG 04

Scientific Title

Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer

Scientific Title:Acronym

N-SOG 04

Region

Japan


Condition

Condition

Unresectable colorectal liver metastases

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 as a conversion therapy for the patients with unresectable or recurrent liver metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Liver resection rate after chemotherapy with Bevacizumab plus mFOLFOX6(R0/R1)

Key secondary outcomes

Liver resection rate(Overall)
Liver resection rate after chemotherapy with Cetuximab plus FOLFIRI(R0/R1)
Response rate
Disease control rate
Safety
Morbidity


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

Chemotherapy with Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6.
Treatment repeats every 14 days for up to 12 courses (6 courses for Cetuximab plus FOLFIRI and 6 courses for Bevacizumab plus mFOLFOX6) .
Liver resection (if possible)

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Histopathologically confirmed colorectal cancer
(2)KRAS wild type(Codon13 and/or 12)
(3)Unresectable liver metastases without extrahepatic metastasis or reccurrence
(4)No prior chemotherapy with Oxaliplatin,Irinotecan,Bevacizumab and Cetuximab
(5)Age: 20 years to 75 years
(6)ECOG performance status: 0-1
(7)No severe organ failure and suitable results of all laboratory test
a. WBC: >=3,000/mm3
b. Neutrophil count: >=1,500/mm3
c. Platelet count: >=100,000/mm3
d. Hemoglobin: >=8.0g/dL
e. Total billilubin: <=2 times the institutional upper limit of normal
f. AST and ALT: <=5 times the institutional upper limit of normal
g. Serum creatinine: <=2 times the institutional upper limit of normal
h. ECG normal or minor abnormality with no-need of treatment
(8)A life expectancy of more than 6 month
(9)Written informed consent will be obtained from each patient before enrollment

Key exclusion criteria

(1)Severe myelosuppression
(2)Diarrhea(watery)
(3)Require treatment of serious infection
(4)Uncontrolled body cavity fluid
(5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis
(6)Severe hypersensitivity
(7)Renal failure or urine protein >=+2 within 1 week before enrollment
(8)Uncontrollable hypertension or diabetes
(9)Significant abnormal ECG or history of cardiovascular disease within 1year
(10)Thrombosis with present or history of thromboembolism within 1year
(11)Intestinal bleeding, ileus, bowel obstruction or peptic ulcer
(12)Perforation of gastrointestinal tract within 1year
(13)Administrated with Aspirin (>=325mg/day) or steroid for rheumatoid arthritis and chronic inflammatory disease
(14)Pregnant and lacting woman,woman with suspected pregnancy, and men of the fertility hope
(15)Have anti-thrombosis drugs within 7days before enrollment
(16)Need to treatment with Atazanavir sulfate
(17)Active multiple cancers
(18)Severe mental illness
(19)Treated continuously with systemic steroids
(20)Any subject judged by the investigator to be unfit for any reason to participate in the study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masato Nagino

Organization

Nagoya University Graduated School of Medicine

Division name

Division of Surgical Oncology

Zip code


Address

65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan

TEL

052-744-2222

Email



Public contact

Name of contact person

1st name
Middle name
Last name Keisuke Uehara

Organization

Nagoya University Graduated School of Medicine

Division name

Division of Surgical Oncology

Zip code


Address

65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan

TEL

052-744-2222

Homepage URL


Email

kuehara@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya Surgical Oncology Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

名古屋大学医学部附属病院(愛知県)他、関連病院


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 10 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

2010 Year 08 Month 25 Day

Date of IRB


Anticipated trial start date

2010 Year 12 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 12 Month 09 Day

Last modified on

2018 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005587


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name