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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000000653
Receipt No. R000000764
Scientific Title Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)
Date of disclosure of the study information 2007/03/26
Last modified on 2016/12/22

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Basic information
Public title Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)
Acronym Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)
Scientific Title Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)
Scientific Title:Acronym Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)
Region
Japan

Condition
Condition Resected liver metastasis from colorectal cancer with curative intent
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Compare the disease-free and overall survival of patients with resected colorectal liver metastases curatively treated with surgery with or without adjuvant oxaliplatin, fluorouracil, and l-leucovorin (mFOLFOX6).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Treatment compliance at 9 courses after beginning mFOLFOX6 (phaseII)
Disease-free survival (phaseIII)
Key secondary outcomes Overall survival, Incidence of adverse events, mode of recurrence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
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 A: Live resection
Interventions/Control_2 B: At 56 to 84 days after hepatectomy, patients receive 2-hour infusion of oxaliplatin IV and l-leucovorin on day 1 followed by fluorouracil (5-FU) bolus and 46-hour infusion on day 1. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
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) Histologically confirmed liver metastasis of colorectal cancer
2) R0 after resection of both primary and seccondary lesions
3) No extrahepatic disease
4) No prior chemotherapy or radiotherapy
5) No prior radiofrequency ablation or cryotherapy for liver metastasis
6) At 42 to 70 days after hepatectomy
7) Patient age is more than 20 and less than 75
8) PS: 0, 1
9) Organ function is kept
10) Written informed consent
Key exclusion criteria 1) Multiple cancer patients
2) Pregnant patients
3) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
4) Psychological disorder
5) Steroid administration
6) Patients must use flucytosine, phenytoin or wargarin potassium
7) Insulin dependent or uncontrollable diabetes mellitus
8) Diarrhea or peripheral neuropathy greater than grade 1
9) Uncontrollable hypertension
10) Unstable angina pectoris, or history of myocardial infarction within six months.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihide Kanemitsu
Organization National Cancer Center Hospital
Division name Colorectal Surgery Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL 03-3542-2511
Email ykanemit@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihide Kanemitsu
Organization JCOG0603 Coordinating Office
Division name Colorectal Surgery Division, National Cancer Center Hospital
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL 03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
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 札幌厚生病院(北海道)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学(東京都)
神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
昭和大学横浜市北部病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
済生会横浜市南部病院(神奈川県)
平塚市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
石川県立中央病院(石川県)
長野市民病院(長野県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
藤田保健衛生大学(愛知県)
国立病院機構京都医療センター(京都府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
堺市立総合医療センター(大阪府)
箕面市立病院(大阪府)
市立吹田市民病院(大阪府)
関西労災病院(兵庫県)
兵庫医科大学(兵庫県)
医療法人薫風会佐野病院(兵庫県)
島根大学医学部(島根県)
岡山済生会総合病院(岡山県)
広島市立広島市民病院(広島県)
県立広島病院(広島県)
福山市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
久留米大学医学部(福岡県)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 26 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
2007 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 26 Day
Last follow-up date
2024 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 03 Month 26 Day
Last modified on
2016 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000764

Research Plan
Registered date File name

Research case data specifications
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Research case data
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