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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005693
Receipt No. R000006735
Scientific Title Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer
Date of disclosure of the study information 2011/06/01
Last modified on 2014/08/05

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Basic information
Public title Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer
Acronym Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer
Scientific Title Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer
Scientific Title:Acronym Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of mFOLFOX6 as the adjuvant chemotherapy after curative resection of lung metastases from colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 5-year survival rate
Key secondary outcomes DFS, Safety, Site of relapse

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 Fluororacil/l-leucovorin plus oxaliplatin (mFOLFOX6)
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) Potentially curative R0 resection was performed for patients with lung metastases from colorectal cancer.
2) Initial lung metastasectomy.
3) Pathological findings should be as follows
i)Histologically proven adenocarcinoma
ii)Less than 4 metastases.
iii)No pulmonary, hilar and mediastinal lymph node metastases.
4) Within 70 days after lung metastasectomy
5) No prior chemotherapy for advanced or metastatic disease.
i)Adjuvant chemotherapy with only FU is allowed.
ii)More than 180 days after the last chemotherapy .
6) No recurrence on chest and abdominal CT or MRI within 4 weeks before enrollment.
7) Age 20-75 years
8) ECOG performance status 0-1
9) Vital organ functions (listed below) are preserved within 1 week prior to entry.
i)White blood cell count >= 3,000/mm3 and <= 12,000/mm3
ii) Platelets>=100,000/mm3
iii)Hemoglobin> =9.0g/dl
iv)Total bilirbin> =1.5mg/dl
v)AST and ALT<= 100IU/l
vi)serum creatinine <= 1.5mg/dl
10) Written informed consent
Key exclusion criteria 1)Adjuvant FU was terminated because of ADR.
2)Multiple cancer patient (within 5 years)
3)Transfusion or blood product or growth factor such as G-CSF less than 14 days prior to entry.
4)Have following severe complications.
i)Bowel obstruction
ii)Uncontrolable heart disease
iii)Severe pulmonary fibrosis, interstitial lung disease, COPD
iv)Uncontrolable hypertension
v)Uncontrolable diabetes
vi)Active peptic ulcer
vii)Uncontrolable diarrhea
viii)bleeding diathesis
ix)HIV infection
x)Active infectious disease
5)Systemic and continuous steroids medication.
6)Severe peripheral neuropathy.
7)History of the serious hypersensitivity for drugs
8)Hepatitis B virus infection
9)Clinically significant mental or psychological disease.
10)Not pregnant
11)Patient who is taking flucytosine, phenytoin or warfarin potassium continuously.
12)Other conditions not suitable for this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nozumu Machida
Organization Shizuoka cancer center
Division name Division of gastrointestinal oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, JAPAN
TEL 055-989-5222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address NambaPlaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 01 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 No longer recruiting
Date of protocol fixation
2011 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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
2011 Year 06 Month 01 Day
Last modified on
2014 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006735

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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