Unique ID issued by UMIN | UMIN000010980 |
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Receipt number | R000012856 |
Scientific Title | Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer |
Date of disclosure of the study information | 2013/06/18 |
Last modified on | 2013/06/17 15:52:36 |
Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer
HORE CC01
Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer
HORE CC01
Japan |
colorecrtal cancer
Gastrointestinal surgery |
Malignancy
NO
To demonstrate the clinical effectiveness of the UFT/LV for the patients with Stage II with risk factors of recurrence and III colorectal cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
treatment complete rate
Safety, Dose Intensity, QOL(EORTC QLQ-C30), Relapse free survival,overall survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Central registration
2
Treatment
Medicine |
UFT capsule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).
UFT E-granule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically confirmed Colorectal cancer
2)high-risk Stage II-III
3) Performance Status (ECOG) 0-1
4) more than 20 years old
5) hasn't received any treatment other than R0 resection.
6) can start the therapy within 8 weeks after surgery.
7) Adequate organ functions
8) Oral intake is possible
9) Written informed consent
A patient:
1)with administration contraindications for UFT,LV.
2)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years).
3)has severe postoperative complications such as serious postoperative infectious disease,anastomotic leak and gastrointestinal bleeding.
4) has severe diarrhea.
5)has severe drug hypersensitivity.
6)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant.
7)with psychosis or psychoneurosis.
8)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
120
1st name | |
Middle name | |
Last name | Hiroyuki Konno |
Hamamatsu University School of Medicine
Second Department of Surgery
1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
1st name | |
Middle name | |
Last name | Kiyotaka Kurachi |
Hamamatsu University School of Medicine
Second Department of Surgery
1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
053-435-2279
HORE
None
Self funding
NO
磐田市立総合病院
浜松医療センター
静岡市立清水病院
松愛会 松田病院
2013 | Year | 06 | Month | 18 | Day |
Unpublished
Open public recruiting
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 06 | Month | 17 | Day |
2013 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012856
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