UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000996 |
|---|---|
| Receipt number | R000001199 |
| Scientific Title | A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer |
| Date of disclosure of the study information | 2008/01/25 |
| Last modified on | 2015/04/18 09:01:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer
Acronym
A phase II study of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer
Scientific Title
A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer
Scientific Title:Acronym
A phase II study of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer
Region
| Japan |
Condition
Condition
liver metastases of colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine safety and efficacy of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
disease free
survival side effect
Key secondary outcomes
overall survival
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
To undergo modified folfox 6 regimen [5-fluorouracil 2.4 g/m2 (24-h continuous infusion), l-leucovorin 200 mg/m2 (2-h intravenous infusion), and oxaliplatin 85 mg/m2 (2-h intravenous infusion) every 2 weeks] for 24 weeks as adjuvant treatment after resection of liver metastases from colorectal cancer.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) First treatment for metastatic liver tumors of colorectal cancer (2) Histologically confirmed metastatic liver tumors of colorectal cancer (3) R0 and R1 after resection of both primary and metastatic tumors (4) No extrahepatic tumors (5) Performance status is 0-2 (6) Function of main organs is kept as below. WBC is from lower normal limit to 12,000/mm3. Neutrophil is over 1,500/mm3. Platet is over 100,000/mm3. Hb is over 9.0/dL. Total bilirubin is within 1.5 times of normal limits. AST and ALT are within 2.5 times of normal limits. ALP is within 2.5 times of normal limits. Creatinin is within normal limits. (7) Written informed consent
Key exclusion criteria
(1) Multiple cancer (2) Prebious history of severe drug-induced allergy (3) Given L-OHP within 6 months before this study (4) Active infection (5) Severe complication (6) Severe sensory disturbance (7) Pregnant (8) Disqualified by attendig doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Hepato-Biliary Pancreatic Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7208
kein_h11@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniharu Yamamoto |
Organization
Miyagi HBPCOG coordinating office
Division name
Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine.
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7208
Homepage URL
kyama@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Miyagi HBPCOG
Institute
Department
Personal name
Funding Source
Organization
Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine.
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2006 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 25 | Day |
Last modified on
| 2015 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001199
