UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.
Acronym	A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.
Scientific Title	A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.
Scientific Title:Acronym	A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of peri-operative chemotherapy for metastatic colorectal cancer with resectable liver metastases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Liver resection rate
Key secondary outcomes

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	Pre-operative chemotherapy(mFOLFOX6) 4cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6) 8cycles, mFOLFOX6(L-OHP85mg/m2, Levofolinate200mg/m2, 5-FU/bolus400mg/m2, 5-FU/continuous2,400mg/m2 every 2 weeks)
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. Patients with histologically proven colorectal cancer 2. With measurable lesions in the liver only (no extrahepatic disease) 3. Resectable synchronous and metachronous liver metastases 4. No prior chemotherapy for colorectal cancer 5. No prior radiotherapy for colorectal cancer 6. Performance status(ECOG):0, 1 7. Life expectancy of more than 3 months 8. Sufficient organ functions 9. Written informed consent
Key exclusion criteria	1. Serious drug hypersensitivity or a history of drug allergy 2. Peripheral neuropathy 3. Active concomitant malignancy 4. Severe infectious disease 5. Serious complications (renal failure or hepatic failure) 6. High blood pressure and diabetic and hypercalcemia that cannot be controlled 7. Symptomatic or asymptomatic but treated heart disease 8. Symptomatic or asymptomatic but treated heart disease 9. Histry of mental disturbances or cerebrovascular attack 10. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 11. Plerral effusion, peritoneal fluid and pericardial fluid 12. Symptomatic brain metastasis 13. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 14. Under coutinuous steroid therapy 15. History of organ transplantation 16. Traumatic gracture of unrecovery 17. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 18. Other conditions not suitable for this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akihiko Middle name Last name Tuchida
Organization	Tokyo Medical University
Division name	department of gastrointestinal and pediatric surgery
Zip code	1600023
Address	6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL	0333426111
Email	k-katsu@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Katsumata
Organization	Tokyo Medical University
Division name	department of gastrointestinal and pediatric surgery
Zip code	1600023
Address	6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL	0333426111
Homepage URL
Email	k-katsu@tokyo-med.ac.jp

Sponsor
Institute	3rd department of surgery Tokyo Medical University
Institute
Department

Funding Source
Organization	Tokyo Medical University
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	Tokyo Medical University
Address	6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
Tel	0333426111
Email	k-katsu@tokyo-med.ac.jp

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	東京医科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 15 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 10 Month 02 Day
Date of IRB
Anticipated trial start date	2012 Year 11 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	2013 Year 01 Month 08 Day
Last modified on	2020 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011399