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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020631
Receipt No. R000023465
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
Date of disclosure of the study information 2016/01/31
Last modified on 2020/01/22

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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/ctr_e/ctr_view.cgi?recptno=R000023465

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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