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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002101
Receipt No. R000002557
Scientific Title Liver resection after chemotherapy for liver only metastasis from colorectal cancer
Date of disclosure of the study information 2009/06/22
Last modified on 2010/12/22

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Basic information
Public title Liver resection after chemotherapy for liver only metastasis from colorectal cancer
Acronym Liver resection after chemotherapy for liver only metastasis from colorectal cancer
Scientific Title Liver resection after chemotherapy for liver only metastasis from colorectal cancer
Scientific Title:Acronym Liver resection after chemotherapy for liver only metastasis from colorectal cancer
Region
Japan

Condition
Condition Liver metastasis of colorectal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the efficacy and safety of liver resection after chemotherapy with modified FOLFOX6 plus BV(bevacizumab) for colorectal cancer with liver-only metastasis (H2, H3).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Curative resection rate (R0 resection rate) [in all subjects]
Key secondary outcomes 1) Resection rate,
Curative resection rate (R0 resection rate) [in all resected subjects],
Conversion rate of nonresectable disease to resectable disease in subjects with nonresectable liver metastasis
Conversion rate of resectable disease to nonresectable disease in subjects with resectable liver metastasis
2) Safety of liver resection after chemotherapy with modified FOLFOX6 plus BV
3) Safety and efficacy of modified FOLFOX6 plus BV
4) Recurrence rate, Overall survival, Progression-free survival (in subjects with resectable liver metastasis), Relapse-free survival (in subjects with curative liver resection)

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 modified FOLFOX6 plus BV(bevacizumab).
Treatment repeats every 14 days for up to 6 courses (5 courses for BV) in the absence of disease progression or unacceptable toxicity.
Liver resection (if possible, 4 to 8 weeks after modified FOLFOX6 plus BV)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histopathologically confirmed adenocarcinoma of the colon and rectum

(2) Complete resection (R0 resection) of primary colorectal cancer more than 28 days prior to entry

(3) No extrahepatic metastasis or reccurrence

(4) The classsification of liver metastasis: H2 or H3

(5) No prior chemotherapy for colorectal cancer

(6) No prior ablation therapy or cryotherapy for liver metastasis

(7) ECOG performance status 0-1

(8) Age: 20 years to 80 years

(9) Life expectancy: at least 12 weeks

(10) Vital organ functions (listed below) are preserved within 2 weeks prior to entry
a) WBC: 4,000/mm3 to 12,000/mm3
b) Neutrophil: 1,500/mm3 and more
c) Platelet count: 100,000/mm3 and more
d) Total billilubin : 2.00mg/dL and under
e) AST and ALT: 100IU/L and under
f) Serum creatinine: 1.20mg/dL and under
g) PT(INR): less than 1.5
f) Urinary protein: grade1 (+1) and under

(11) Signed written informed consent
Key exclusion criteria (1) Transfusion or blood product or growth factor such as G-CSF less than 7 days prior to entry

(2) Prior severe drug allergy

(3) Radiotherapy less than 4 weeks prior to entry

(4) Chronic daily treatment with anti-platelet drug such as high dose aspirin (more than 325mg/day) or other NSAID (temporary use of NSAIDs for cancer pain are permitted)

(5) Presence of cerebrovascular disease or symptoms less than 1 year prior to entry

(6) Presence of uncontrolled pleural effusion or ascites

(7) Presence of cardiac effusion

(8) Presence of active infection

(9) Presence of viral hepatitis

(10) Other active malignancy or multiple colorectal cancers

(11) Severe postoperative complications(e.g. postoperative infection, anastomotic dehiscence,or paralytic ileus)

(12) Uncontrolled co-mobility, such as hypertension, diabetes, arrhythmia, or other medical conditions

(13) Hemorrhage/bleeding,paralytic ileus, obstruction, or ulceration of gastrointestinal tract

(14) Perforation of gastrointestinal tract less than 1 year prior to entry

(15) Grade 2 diarrhea or sensory neuropathy

(16) Chronic systemic treatment of corticosteroid

(17) Phenytoin, Warfarin potassium, or flucytosin administration

(18) Surgery, biopsy with skin incision, or traumatic injury with suture less than 4 weeks prior to entry

(19) Nursing or pregnant females, or females or males with female partners who are planning to pregnancy

(20) Participation in other clinical trial

(21) Any other serious medical condition that would preclude study treatment
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Sugihara, M.D., PhD
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical & Dental University
Division name Dept. of Surgical Oncology,
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL 03-5803-5261
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Uetake, M.D., PhD
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical & Dental University
Division name Dept. of Surgical Oncology,
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL 03-5803-5261
Homepage URL http://www.ibri-kobe.org/
Email h-uetake.srg2@tmd.ac.jp

Sponsor
Institute Tokyo Medical & Dental University
Institute
Department

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
2009 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
Date of protocol fixation
2009 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 22 Day
Last modified on
2010 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=R000002557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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