UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004683 |
|---|---|
| Receipt number | 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 12:47:50 |
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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
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
Sponsor or person
Institute
Tohoku - Six Universities Research Group by Experts (T-SURGE)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005556
