UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007787
Receipt number R000009175
Scientific Title Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer
Date of disclosure of the study information 2012/04/19
Last modified on 2016/12/09 22:56:03

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Basic information

Public title

Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer

Acronym

EXPERT

Scientific Title

Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer

Scientific Title:Acronym

EXPERT

Region

Japan


Condition

Condition

Resectable colorectal liver metastases

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and the safety of surgery and peri-operative chemotherapy for metastatic colorectal cancer with resectable liver metastases as randomized phase lll trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival, Disease free survival, Safety, Postoperative complications, R0 rate, Liver resectability, Response rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Surgical hepatectomy followed by chemotherapy (mFOLFOX6) 12cycles.
mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly)

Interventions/Control_2

Pre-operative chemotherapy(mFOLFOX6 plus cetuximab) 6cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6 plus cetuximab) 6cycles. Cetuximab(loading dose 400mg/m2, 250 mg/m2/week), mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly)

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) Patients with histologically proven colorectal cancer
(2) Resectable synchronous and metachronous liver metastases
(3) Metastatic colorectal cancer with EGFR expressed
(4) KRAS wild type in codon 12, 13
(5) Age over 20 years
(6) ECOG Performance Status(PS) 0-1
(7) Presence of measurable lesion in liver (RECIST Ver.1.1)
(8) No prior chemotherapy for colorectal cancer
(9) Patiens have enough organ function for study treatment
(10) Life expectancy of more than 3 months
(11) Written informed consent

Key exclusion criteria

(1) Extrahepatic metastases or history of extrahepatic metastases
(2) Metachronous 1 liver metastasis
(3) More than 9 liver metastases
(4) Prior local therapy for liver metastases
(5) Severe comorbidity
(6) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
(7) Severe infectious disease
(8) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding . Women with a positive pregnancy test
(9) Psychological disorder
(10) Considered not appropriate for surgery

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Kokudo

Organization

The University of Tokyo

Division name

Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kiyoshi Hasegawa, Masaru Oba

Organization

The University of Tokyo

Division name

Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5800-8779

Homepage URL

http://www.ibri-kobe.org/

Email

expert-office@umin.org


Sponsor or person

Institute

Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Foundation for Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2012 Year 04 Month 19 Day


Related information

URL releasing protocol

http://www.ibri-kobe.org/

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

No longer recruiting

Date of protocol fixation

2012 Year 02 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 05 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

2012 Year 04 Month 19 Day

Last modified on

2016 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009175


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name