UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020631 |
|---|---|
| Receipt number | 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 10:01:50 |
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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
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
rtoda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023465
