Unique ID issued by UMIN | UMIN000012618 |
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Receipt number | R000014438 |
Scientific Title | Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer. |
Date of disclosure of the study information | 2013/12/18 |
Last modified on | 2018/12/21 15:15:53 |
Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.
Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.(KSCC1303)
Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.
Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.(KSCC1303)
Japan |
Colon cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of C-SOX as adjuvant chemotherapy for Stage III colon cancer.
Efficacy
Exploratory
Pragmatic
Phase II
3-years Disease free survival rate
The rate of completion of treatment as planned
Adverse event
Relative dose intensity
Disease free survival
Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oxaliplatin 130 mg/m2 (day 1)
S-1 80-120 mg/day (day1-14)
to be repeated every 3 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Written informed consent
2) Patients who are judged to be suitable for receiving this protocol therapy by physician
3) Pathologically and Histologically confirmed colon adenocarcinoma
4) No prior chemotherapy and radiotherapy
5) Stage III, pathologically confirmed colon adenocarcinoma
6) R0 resection with D2 or D3 lymph node dissection was performed
7) Registration within 8 weeks after surgery
8) Age >= 20 years old
9) PS 0-1
10) Be able to take oral drugs
11) Recovery of postoperative complications
12) Required baseline laboratory parameters (within 14 days before registration):
i) Neu >= 1,500/mm3
ii) Hb >= 9.0g/dL
iii) Plt >= 100,000/mm3
iv) AST <= 100IU/L
v) ALT <= 100IU/L
vi) T-Bil < 2.0mg/dl
vii) Ccr >= 60mL/min
1) History of the severe hypersensitivity
2) Active other malignancies
3) Sensory neuropathy >= Grade 1
4) Diarrhea >= Grade 2
5) Active infections
6) History of mental disorder, central nerve disorder
7) Serious complication
8) Blood transfusion or hemopoietic factors (e.g. G-CSF) within 14 days
9) Pleural effusion, peritoneal fluid that needs treatment
10) Hemorrhagic diathesis, coagulation disorder
11) Patients who need flucytosine, phenytoin or warfarin potassium
12) Requiring steroid drug
13) Pregnant or lactating woman and man who hope for Partner's pregnant
14) Positive for HBs antigen and HCV antibody
15) Investigator's judgement
85
1st name | |
Middle name | |
Last name | Shoji Natsugoe |
Kagoshima University
Department of Digestive Surgery, Breast and Thyroid Surgery
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
092-631-2920
kscc2@cres-kyushu.or.jp
1st name | |
Middle name | |
Last name | KSCC |
Clinical Research Support Center Kyushu
KSCC
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
092-631-2920
kscc2@cres-kyushu.or.jp
Kyushu Study group of Clinical Cancer(KSCC)
Yakulto Honsha Co.
Profit organization
NO
2013 | Year | 12 | Month | 18 | Day |
Published
Completed
2013 | Year | 11 | Month | 22 | Day |
2014 | Year | 02 | Month | 01 | Day |
2013 | Year | 12 | Month | 18 | Day |
2018 | Year | 12 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014438
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