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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009725
Receipt No. R000011399
Scientific Title A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.
Date of disclosure of the study information 2013/01/15
Last modified on 2020/07/15

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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/ctr_e/ctr_view.cgi?recptno=R000011399

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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