UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009530 |
|---|---|
| Receipt number | R000011192 |
| Scientific Title | Non-resectable colorectal liver metastases of KRAS mutant type treated with oxaliplatin, fluorouracil and l-leucovorin plus bevacizumab induction toward liver R0 resection trial |
| Date of disclosure of the study information | 2012/12/13 |
| Last modified on | 2015/12/02 21:47:02 |
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Basic information
Public title
Non-resectable colorectal liver metastases of KRAS mutant type treated with oxaliplatin, fluorouracil and l-leucovorin plus bevacizumab induction toward liver R0 resection trial
Acronym
NEXTO-mt
Scientific Title
Non-resectable colorectal liver metastases of KRAS mutant type treated with oxaliplatin, fluorouracil and l-leucovorin plus bevacizumab induction toward liver R0 resection trial
Scientific Title:Acronym
NEXTO-mt
Region
| Japan |
Condition
Condition
Non-resectable colorectal liver metastases (KRAS mutant type)
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of surgery and modified FOLFOX6+bevacizumab as induction chemotherapy for metastatic colorectal cancer with non-resectable KRAS mutant liver metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Liver metastases R0 resection rate
Key secondary outcomes
Safety(AE), All R0 resection rate, Liver metastases R0+R1 resection rate, Central review of resectability, Tumor reduction rate, Response rate, Disease-free survival, Progression-free survival, Overall Survival, Histopathologic assessment
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 | Maneuver |
Interventions/Control_1
Induction chemotherapy (mFOLFOX6 + bevacizumab) 4-12 courses plus additional mFOLFOX6 1 course, followed by surgery, followed by post-operative chemotherapy (mFOLFOX6 + bevacizumab) 0-7 courses.
*(Inducion plus post-operative adjuvant chemotherapy: up to a total of 12 courses)
.mFOLFOX6
Bevacizumab 2.5mg/kg/week
L-OHP 85mg/m2
l-LV 200mg/m2
5-FU 400mg/m2 (bolus)
5-FU 2400mg/m2 (infusion)
every 2weeks
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) Patients with histologically proven colorectal cancer
(2) No prior local therapy for liver metastases and presence of measurable lesion in the liver (RECIST Ver.1.1)
(3)
A) Non-resectable or more than 5 liver limited metastases
B) Non-resectable or more than 5 liver metastases with resectable extrahepatic metastases (except for peritoneal dissemination)
C) Initial or recurrent liver metastases are permitted if liver metastases are metachronous
(4) Resectable primary lesion and extrahepatic metastases except as noted below;
A) Primary lesion : Patients with imminent risk of obstruction or significant bleeding
B) Extrahepatic metastases : Patients with peritoneal dissemination
(5) Metastatic colorectal cancer with KRAS mutant type
(6) Age over 20 years
(7) ECOG Performance Status(PS): 0-1
(8) No prior chemotherapy for colorectal cancer
(9) Patients have enough organ function for study treatment
- neutrophil count: >=1,500/mm3
- platelet: >=100,000/mm3
- serum bilirubib level: <=1.5mg/dL
- serum creatinine level: <=1.5mg/dL
- AST: <=100IU/L
- ALT: <=100IU/L
- albumin: >=3.0g/dL
- Urinary protein: 1+<=
- PT(INR): <1.5
(10)Life expectancy of more than 3 months
(11)Written informed consent
Key exclusion criteria
(1) Prior local therapy for liver metastases
(2) Severe comorbidity
(3) A past history of drug allergy (needs continuation therapy)
(4) A past history of Interstitial lung disease
(5) A past history of hemoptysis
(6) Patients who has not recovered from previous cancer treatment to less than Grade 1 toxicity
(7) Fully recovered from surgical treatment within 4 weeks before registration
(8) Received widespread radiation therapy within 6 weeks before registration
(9) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
(10) Severe infectious disease
(11) Pleural effusion, ascites fluid and the pericardial fluid needing treatment
(12) Watery diarrhea (watery colostomy output without trouble during patient's daily living is allowed)
(13) Chronic systemic treatment of corticosteroid
(14) Bleeding tendency, coagulation disorder, abnormality of coagulation factor, or administered anticoagulant
(15) HBsAg positive, HCV-Ab positive or HIV positive
(16) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
(17) Psychological disorder
(18) Considered not appropriate for surgery
(19) Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
The University of Tokyo
Division name
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
kokudo-2su@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Hasegawa, Masaru Oba |
Organization
The University of Tokyo
Division name
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
nexto2-office@umin.org
Sponsor or person
Institute
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
国立国際医療センター国府台病院(千葉県)、東邦大学医療センター 大森病院(東京都)、関東労災病院（神奈川県）、虎の門病院（東京都）、がん研有明病院（東京都）、防衛医科大学校病院（埼玉県）、JR東京総合病院（東京都）、東京新宿メディカルセンター（東京都）、NTT東日本関東病院（東京都）、国立国際医療研究センター（東京都）、東都文京病院（東京都）、東京高輪病院（東京都）、
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 13 | 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
| 2012 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 12 | Day |
Last modified on
| 2015 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011192
