UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013324 |
|---|---|
| Receipt number | R000015551 |
| Scientific Title | A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study] |
| Date of disclosure of the study information | 2014/03/04 |
| Last modified on | 2022/04/26 13:49:22 |
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Basic information
Public title
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
Acronym
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
Scientific Title
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
Scientific Title:Acronym
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
Region
| Japan |
Condition
Condition
Liver Metastases of Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity
of adjuvant XELOX for post curative resection for liver metastasis of colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year Disease-Free Survival
Key secondary outcomes
Overall Survival
relative dose intensity
Adverse events
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
Surgical hepatectomy followed by
chemotherapy (XELOX)8cycles.
<XELOX>
(L-OHP 130 mg/m2 day1 ,
Capecitabine 2,000mg/m2/day
day1-14)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Histlogically proven colorectal
carcinoma.
(2)Curatively resected metastatic liver tumors of colorectal cancer.
(3)No extrahepatic metastatis.
(4)No history of
thermocoagulation therapy and
cryotherapy for livermetastasis.
(5)Within 42-70 days from the date of liver resection.
(6)Age >= 20 years.
(7)Performance status(ECOG) of 0-1.
(8)Adequate bone marrow, hepatic,
renal, cardiac and respiratory
functions.
(9)Cases that meet all the following criteria (Check all items using the test values of the latest within 14 days prior to entry).
1. Neutrophil count >=1500/mm3
2. Hemoglobin >=8.0g/dL (That you have not done a blood transfusion within 14 days prior to entry).
3. Platelets>=100,000/mm3
4. Total bilirubin <=2.0g/dL
5. AST <=100IU/L
6. AST <=100IU/L
7. Creatinine<=1.5mg/dL
(10)Written informed consent.
Key exclusion criteria
(1) Synchronous multiple malignancy
(2)Previously treated L-OHP.
(3) More than 180days after the last
chemotherapy.
(4)Pregnant or nursing.
(5) Severe peripheral neuropathy.
(6) History of severe anaphylaxis or allergia
(7)Active infection
(8)Severe mental disorder.
(9) Severe comorbidity.
(10)Systemic steroid user.
(11)Patients under treatment with
flucytosine,phenytoin,warfarin
potassium.
(12)Hepatitis B virus infection.
(13)Watery diarrhea.
(14)Consider not appropriate for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Tomita |
Organization
Hyogo College of Medicine
Division name
Department of Surgery
Zip code
663-8501
Address
Mukogawa-cho 1-1, Nishinomiya-city,Hyogo
TEL
0798-45-6370
ntomita@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Naotoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Osaka International Cancer Institute
Division name
Department of Medical Oncology
Zip code
537-8511
Address
Otemae 3-1-69, chuo-ward ,Osaka
TEL
06-6945-1181
Homepage URL
sugimoto-na2@mc.pref.osaka.jp
Sponsor or person
Institute
Hyogo College of Medicine,
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku
Tel
+81669451181
na2-sugimoto@oici.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015551
