Unique ID issued by UMIN | UMIN000005199 |
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Receipt number | R000006173 |
Scientific Title | Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer |
Date of disclosure of the study information | 2011/03/05 |
Last modified on | 2011/12/19 23:03:27 |
Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer
Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer
Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer
Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer
Japan |
Metastatic colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Response Rate
Progression Free Survival(PFS)
Overall Survival(OS)
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bevacizumab with SOX (S-1 plus L-OHP) repeat every 21 days until discontinuance criteria.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients with histologically proven colorectal cancer
(2) Metastatic colorectal cancer
(3) Patients with comfirmed target lesion
(4) Patients with metastatic colorectal cancer who had previously received first-line therapy with an irinotecan-based regimen.
(5) Life expectancy of more than 3 months
(6) Age over 20
(7) ECOG Performance Status 0-1
(8) Patients have enough organ function for study treatment.
(9) Enable to internal use
(10) Written informed consent
(1) History of severe allergy
(2) Active double cancer
(3) Severe infectious disease
(4) Peripheral neuropathy
(5) Uncontrolled hypertention
(6) Sever comorbidity(interstitial lung disease or pulmonary fibrosis, heart failure, renal failure, liver failure, etc)
(7) Massive pleural or abdominal effusion
(8) Patient with the diarrhea
(9) Symptomatic brain metastases
(10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
(11) Severe mental disorder
(12) Systemic administration of corticosteroids
(13) Uric protein 2+
(14) Prior radiotherapy for primary and metastases tumors
(15) Thrombosis, cerebral infraction, cardiac infraction or pulmonary infraction within 6 months
(16) Patients who underwent surgery within 4 weeks
(17) Systemic administration of antiplatelet drug
(18) Patients with known bleeding disorders or clotting disorder
(19) Previous history of adjuvant chemotherapy with L-OHP
(20)Any other cases who are regarded as inadequate for study enrollmet by investigators
33
1st name | |
Middle name | |
Last name | Yoshinori Sakai |
Tsuchiura kyodo general hospital
Department of Gastroenterology
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
1st name | |
Middle name | |
Last name | Toshiki Masuishi |
Tsuchiura kyodo general hospital
Department of Gastroenterology
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
Tsuchiura kyodo general hospital
none
Self funding
NO
2011 | Year | 03 | Month | 05 | Day |
Unpublished
Terminated
2011 | Year | 01 | Month | 24 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 05 | Day |
2011 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006173
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