Unique ID issued by UMIN | UMIN000024330 |
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Receipt number | R000027804 |
Scientific Title | A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer |
Date of disclosure of the study information | 2016/10/07 |
Last modified on | 2016/10/07 14:49:03 |
A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
A phase II study of UFT/LV and bevacizumab treatment
A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
A phase II study of UFT/LV and bevacizumab treatment
Japan |
unresectable metastatic/recurrent colorectal cancer
Gastroenterology | Hematology and clinical oncology | Surgery in general |
Gastrointestinal surgery | Adult |
Malignancy
NO
We investigated the efficacy and safety of combination therapy of UFT/LV and Bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer.
Efficacy
Exploratory
Pragmatic
Phase II
Progression free survival
Overall survival, Time to treatment failure, Overall response rate, Disease control rate, Adverese
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
UFT(300mg/m2/day) and LV(75mg/day) are simultaneously given 3times per day for 5days, followed by 2-day rest. Bevacizumab is administerd by every 3 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with histologically verified adenocarcinoma of the colon and rectum
2) Patients with Unresectable metastatic/recurrent colorectal cancer
3) Patients not appropriate for intensive therapy, such as FOLFOX or FOLFIRI
4) Patents without a previous chemotherapy or radiation therapy
5) Patient's age over 20 years-old
6) ECOG Performance status of 0-2
adequate bone marrow, liver, renal, and cardiac function; no prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; ; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.
1)Patients with a past history of severe drug allergy 2)no other co-existing malignancy or malignancy within the last five years prior to enrollment other than non-melanoma skin cancer or in situ carcinoma of the cervix 3)patients were pregnant or lactating 4)Patients with psychiatric illness 5)Patients with severe co-morbidities (renal failure, liver dysfunction, uncontrolable diabetes mellitus and hypertension, heart failure) 6)Patients with massive ascites or hydrothorax 7)Patients with a symptomatic brain metastasis 8)Patients with abdominal surgery within 28days 9)Patients with perforated disease 10)Patients with thrombosis 11)Patiens with 3+ proteinurea
35
1st name | |
Middle name | |
Last name | Kiyoshi Maeda |
Osaka City University Graduate School of Medicine
Dept of Surgical Oncology
Asahimachi, Abeno-ku, Osaka
06-6645-3838
m1378386@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Kiyoshi Maeda |
Osaka City University Graduate School of Medicine
Dept of Surgical Oncology
Asahimachi, Abeno-ku, Osaka
06-6645-3838
m1378386@med.osaka-cu.ac.jp
Dept of Surgical Oncology Osaka City University Graduate School of Medicine
Dept of Surgical Oncology Osaka City University Graduate School of Medicine
Self funding
NO
2016 | Year | 10 | Month | 07 | Day |
Unpublished
2016 | Year | 09 | Month | 23 | Day |
2016 | Year | 09 | Month | 26 | Day |
2016 | Year | 10 | Month | 07 | Day |
2016 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027804
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