UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases from colorectal cancer
Acronym	Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases from colorectal cancer (LOFT trial)
Scientific Title	Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases from colorectal cancer
Scientific Title:Acronym	Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases from colorectal cancer (LOFT trial)
Region	Japan

Condition
Condition	resectable liver metastases from colorectal cancer
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety and the efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases from colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the completion rate
Key secondary outcomes	overall survival, relapse-free survival, 3-year relapse-free survival rate, adverse event, relative dose intensity, the correlation between the remnant liver ratio and the completion rate, change over time about sensory nerve disorder

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	Postoperative adjuvant chemotherapy with L-OHP base regimen (6courses of mFOLFOX6 or 4courses of CapeOX) followed by 3courses of UFT plus LV.
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. Histlogically proven colorectal carcinoma. 2. Curatively resected metastatic liver tumors of colorectal cancer. 3. No extrahepatic metastasis. 4. Within 4-8 weeks from the date of liver resection. 5. Age >= 20 years, Age <= 80 years 6. The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1 7. Cases that meet all the following criteria (Check all items using the test values of the latest within 14 days prior to entry). i.Neutrophil count >=1500/mm3 ii.Platelets>=100,000/mm3 iii.Hemoglobin >=9.0g/dL iv. Total bilirubin <=1.5g/dL v. AST, ALT, ALP <=2.5ULN vi. Creatinine<=1.5mg/dL 8. Checked chest and abdominal CT within 30 days. 9. Promised of more than 3 months survival 10.Written informed consent.
Key exclusion criteria	1. Neurologic symptom due to cerebrovascular diseases. 2. Cardiac diseases. 3. Uncontrollable hypertension, Uncontrollable diabetes. 4. Renal dysfunction. 5. Uncontrollable gastrointestinal ulcer 6. Prior hypersensitivity reaction to drugs used in this trial. 7. Suspected of DPD Deficiency. 8. Prior treatment with L-OHP within 6 months. 9. Treatment with MTX to RA. 10. Uncontrollable infectious diseases. 11. Uncontrollable diarrhea. 12. Neuropathy >= Grade2 according to the CTCAE. 13. Body fruid (ascites,pleural effusion.pericardiac effsion). 14. Multiple malignancies to be treated within 5 years. 15. Prior treatment with immunosuppressant and transplantation. 16. Pregnant. 17. Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Seo
Organization	Kyoto University Hospital
Division name	Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code	6068507
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-751-3608
Email	rutosa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Rei Middle name Last name Toda
Organization	Kyoto University Hospital
Division name	Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code	6068507
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-751-3608
Homepage URL
Email	rtoda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Other 15 hospitals
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 31 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	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 18 Day
Date of IRB	2016 Year 01 Month 20 Day
Anticipated trial start date	2016 Year 01 Month 31 Day
Last follow-up date	2024 Year 01 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 19 Day
Last modified on	2020 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023465