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 |
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
A phase II study of resection followed
capecitabine + oxaliplatin for liver metastasis of colorectal cancer.
[REX study]
Japan |
Liver Metastases of Colorectal Cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and toxicity
of adjuvant XELOX for post curative resection for liver metastasis of colorectal cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
3-year Disease-Free Survival
Overall Survival
relative dose intensity
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Surgical hepatectomy followed by
chemotherapy (XELOX)8cycles.
<XELOX>
(L-OHP 130 mg/m2 day1 ,
Capecitabine 2,000mg/m2/day
day1-14)
20 | years-old | <= |
Not applicable |
Male and Female
(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.
(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.
50
1st name | Naohiro |
Middle name | |
Last name | Tomita |
Hyogo College of Medicine
Department of Surgery
663-8501
Mukogawa-cho 1-1, Nishinomiya-city,Hyogo
0798-45-6370
ntomita@hyo-med.ac.jp
1st name | Naotoshi |
Middle name | |
Last name | Sugimoto |
Osaka International Cancer Institute
Department of Medical Oncology
537-8511
Otemae 3-1-69, chuo-ward ,Osaka
06-6945-1181
sugimoto-na2@mc.pref.osaka.jp
Hyogo College of Medicine,
Department of Surgery
None
Self funding
Osaka International Cancer Institute
3-1-69 Otemae, Chuo-ku
+81669451181
na2-sugimoto@oici.jp
NO
2014 | Year | 03 | Month | 04 | Day |
Partially published
25
Terminated
2014 | Year | 02 | Month | 07 | Day |
2014 | Year | 02 | Month | 07 | Day |
2014 | Year | 02 | Month | 07 | Day |
2022 | Year | 02 | Month | 06 | Day |
2014 | Year | 03 | Month | 04 | Day |
2022 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015551