UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000003796
Receipt number	R000004527
Scientific Title	Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group
Date of disclosure of the study information	2010/06/22
Last modified on	2010/06/29 16:51:51

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Basic information

Public title

Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group

Acronym

Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases
(COMET)

Scientific Title

Scientific Title:Acronym

Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases
(COMET)

Region

Japan

Condition

Resectable Liver Metastases From Colorectal Cancer

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Multicenter phase II study of oxaliplatin plus fluoro-uracil l-Leucovorin or oxaliplatin plus capecitabine and MoAb as neoadjuvant chemotherapy for patients with resectable liver metastases from colorectal cancer in Japan

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

anti-tumor effect
overall survival
R0 resection 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

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Patients receive FOLFOX regimen or XELOX (oxaliplatin plus capecitabin) and MoAb as neoadjuvant protocol

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,Histologically confirmed colorectal cancer
2,KRAS mutation status was determined
3,Resectable liver metastases with or without lymphnode metastases
4,No extrahepatic disease
5,No prior chemotherapy , immunotherapy and radiotherapy except adjuvant chemotherapy if ended >=6 months before study entry
6,No prior radiofrequency ablation or surgery for liver metastases
7,No prior radiotherapy for liver metastases
8,ECOG performance status <=1
9,Adequate hematological, renal and liver function
10,Written informed consent

Key exclusion criteria

1,Serious myelosuppression
2.Serious infection
3,Large quantity of abdominal or pleural effusion
4,cardiovascular disease, complication
5,sensory alteration or paresthesia interfering with function
6,No brain or bone metastasis, active double cancer
7,No hypersensitivity for test drugs
8,Serious pulmonary disease
9,Liver cirrhosis
10,Multiple cancer patient

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Ken Kondo

Organization

Nagoya Medical Center

Division name

Department of Surgery

Zip code

Address

4-1-1Sannomaru Naka-Ku Nagoyasi, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name

Organization

Nagoya University Graduate School of Medicine, Nagoya, Japan

Division name

Young Leaders Program in Medical Administration

Zip code

Address

65 Turumaicho Shouwa-ku, Nagoya Japan

TEL

Homepage URL

Email

Sponsor or person

Institute

Epidemiological and Clinical Research Information Network

Institute

Department

Personal name

Funding Source

Organization

Epidemiological and Clinical Research Information Network

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2010 Year 06 Month 22 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

Open public recruiting

Date of protocol fixation

2010 Year 05 Month 26 Day

Date of IRB

Anticipated trial start date

2010 Year 06 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 06 Month 21 Day

Last modified on

2010 Year 06 Month 29 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004527

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name