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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004683
Receipt No. R000005556
Scientific Title Multicenter phase II trial of mFOLFOX6 with cetuximab as active chemotherapy regimen for liver metastases inappropriate for curative resection in EGFR positive and KRAS wild type colorectal cancer
Date of disclosure of the study information 2010/12/08
Last modified on 2016/03/11

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Basic information
Public title Multicenter phase II trial of mFOLFOX6 with cetuximab as active chemotherapy regimen for liver metastases inappropriate for curative resection in EGFR positive and KRAS wild type colorectal cancer
Acronym FOCAL trial
Scientific Title Multicenter phase II trial of mFOLFOX6 with cetuximab as active chemotherapy regimen for liver metastases inappropriate for curative resection in EGFR positive and KRAS wild type colorectal cancer
Scientific Title:Acronym FOCAL trial
Region
Japan

Condition
Condition EGFR positive and KRAS wild type colorectal cancer with liver metastases inappropriate for curative resection
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of mFOLFOX6 with cetuximab as active chemotherapy regimen for liver metastases inappropriate for curative resection in EGFR positive and KRAS wild type colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes R0 resection rate (Curative resection rate)
Key secondary outcomes Resection rate of liver metastases, Tumor response rate, Adverse events

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 cetuximab.
Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Liver resection (if possible, 6 weeks after modified FOLFOX6 plus cetuximab)
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 proven colorectal cancer in EGFR positive and KRAS wild type

(2) Measurable synchronous liver metastases or measurable metachronous liver metastases.
- Synchronous liver metastasis:
No prior treatment except for original resection. After original resection, curative resection past more than 6 weeks, non-curative resection past more than 4 weeks.
- Metachronous liver metastasis:
No prior treatment for liver metastases, more than 6 months after original postoperative adjuvant therapy

(3) All metastases is unresectable with margin. Or residual liver less than 40% after resection.

(4) Age >=20

(5) The Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) 0-2

(6) Life expectancy of more than 3 months

(7) With a written informed consent

(8) Vital organ functions (listed below) are preserved within 2 weeks prior to entry

i) Medullary function
WBC >= 3,000/mm^3
Neurtophils >= 1,500/mm^3
Platelets >= 100,000/mm^3

ii) Liver function
AST(GOT) <= ULN*5
ALT(GPT) <= ULN*5
Total bilirubin <= ULN*2

iii) Renal function
Creatinine <= ULN*2
Key exclusion criteria (1) Uncontrolled extrahepatic lesion

(2) Symptomatic brain metastasis

(3) Cardiac disease (over Grade 2 by CTCAE v4.0), or myocardial infarction within 1 year

(4) Past or current history (within 5 years) of malignant disease, except for the early cancer healed clearly

(5) Interstitial lung disease, or pulmonary fibrosis

(6) Serious infectious disease

(7) Serious complication (kidney failure, liver failure , hypertension, etc)

(8) Peripheral neuropathy (over Grade 1 by CTCAE v4.0)

(9) No willing of birth-control. Or pregnant or lactating women

(10) Serious drug hypersensitivity or history of drug allergy of Fluorouracil, Levofolinate calcium and/or Oxaliplatin

(11) Participation in other clinical trial within 4 weeks

(12) History of serious drug hypersensitivity

(13) Previously received on anti-EGFR antibody

(14) Case whom investigator deny the enrollment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Go Wakabayashi
Organization Iwate Medical University
Division name Dept. of Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Nitta
Organization Iwate Medical University
Division name Dept. of Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL
Homepage URL
Email

Sponsor
Institute Tohoku - Six Universities Research Group by Experts (T-SURGE)
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 弘前大学大学院医学研究科 消化器外科学講座(青森県)
秋田大学大学院医学系研究科 消化器外科講座(秋田県)
岩手医科大学 外科学講座(岩手県)
東北大学大学院医学系研究科 外科病態学講座 先進外科学分野(宮城県)
東北大学大学院医学系研究科 外科病態学講座 消化器外科学分野(宮城県)
山形大学医学部 消化器・一般外科 乳腺・甲状腺外科(山形県)
福島県立医科大学医学部 臓器再生外科学講座(福島県)
福島県立医科大学医学部 器官制御外科学講座(福島県)

他関連病院

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 08 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 07 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2017 Year 12 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
2010 Year 12 Month 08 Day
Last modified on
2016 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005556

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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