Unique ID issued by UMIN | UMIN000004029 |
---|---|
Receipt number | R000004839 |
Scientific Title | Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma |
Date of disclosure of the study information | 2010/09/01 |
Last modified on | 2010/08/10 21:35:47 |
Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Japan |
Cases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and efficacy of S-1/ L-OHP(SOX) as adjuvant chemotherapy after resection of liver metastasis from colorectal carcinoma
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Discontinuation rate associated with toxicity
Relapse-free survival
Disease-free survival
Toxicity
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Oxaliplatin(130mgm-2) was administered as a 2-h infusion every 3 weeks.
Patients received S-1 orally twice daily from the evening of day 1 to
the morning of day 15 at a dose of 40 mg (BSA<1.25m2), 50 mg
(≥1.25, <1.50m2), or 60mg (≥1.50m2) followed by a 7-day rest
period in the 3-weekly schedule.
Oxaliplatin(100mgm-2) was administered as a 2-h infusion every 3 weeks.
Patients received S-1 orally twice daily from the evening of day 1 to
the morning of day 15 at a dose of 40 mg (BSA<1.25m2), 50 mg
(≥1.25, <1.50m2), or 60mg (≥1.50m2) followed by a 7-day rest
period in the 3-weekly schedule.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients undergoing first resection for liver metastasis from colorectal carcinoma. No residual disease after surgery and no disease except for liver metastasis and the primary colorectal carcinoma.
The patients with other malignant disease, post-operative severe complications, and surgical margin positivity.
80
1st name | |
Middle name | |
Last name | Mitsuyoshi Ota |
Yokohama City University Graduate School of Medicine
Gastroenterological surgery
3-9, Fukuura, Kanazawa-ku, Yokohama
045-787-2650
1st name | |
Middle name | |
Last name | Mitsuyoshi Ota |
Yokohama City University Graduate School of Medicine
Gastroenterological surgery
3-9, Fukuura, Kanazawa-ku, Yokohama
045-787-2650
m_ota@yokohama-cu.ac.jp
Yokohama City University Graduate School of Medicine
Gastroenterological surgery
Yokohama City University Graduate School of Medicine
Self funding
NO
2010 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2010 | Year | 07 | Month | 26 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 08 | Month | 10 | Day |
2010 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004839