Unique ID issued by UMIN | UMIN000005191 |
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Receipt number | R000005366 |
Scientific Title | XELOX stop-and-go trial:A phase 2 study of 1st line chemotherapy for unresectable or recurrent colorectal cancer. |
Date of disclosure of the study information | 2011/03/06 |
Last modified on | 2012/03/04 17:59:13 |
XELOX stop-and-go trial:A phase 2 study of 1st line chemotherapy for unresectable or recurrent colorectal cancer.
FMOG1001 XELOX stop and Go
XELOX stop-and-go trial:A phase 2 study of 1st line chemotherapy for unresectable or recurrent colorectal cancer.
FMOG1001 XELOX stop and Go
Japan |
Unresectable or recurrent colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of 1st line chemotherapy of capecitabine and oxaliplatin (XELOX) stop-and-go schedule in unresectable or recurrent colorectal cancer patients.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Progression free survival
Response rate
Time to treatment failure
Overall survival
Safety plofiles(Rate of Grade 3 neurotoxicity, adverse events)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
XELOX therapy 6 courses, followed by XELODA 6 courses, then XELOX
20 | years-old | <= |
75 | years-old | >= |
Male and Female
From 25 to 75 years old, colorectal cancer, PS 0-1, chemotherapy naive, proper organ function, not indicated for bevacizumab for some reasons.
Double cancer, severe allergic history, active infections, severe complications
37
1st name | |
Middle name | |
Last name | Eishi Baba |
Kyushu University Hospital
Hematology and Oncology
3-1-1, Maedashi, Higashi-ku, Fukuokashi
1st name | |
Middle name | |
Last name |
Kyushu University Hospital
Hematology and Oncology
Hematology and Oncology, Kyushu University Hospital
Nothing
Self funding
NO
2011 | Year | 03 | Month | 06 | Day |
Unpublished
Open public recruiting
2010 | Year | 04 | Month | 28 | Day |
2010 | Year | 05 | Month | 01 | Day |
2011 | Year | 03 | Month | 04 | Day |
2012 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005366
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