Unique ID issued by UMIN | UMIN000005209 |
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Receipt number | R000006142 |
Scientific Title | A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy (OGSG 1102) |
Date of disclosure of the study information | 2011/04/01 |
Last modified on | 2020/09/16 21:47:52 |
A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
Japan |
colo-rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To confirm the feasibility and effectiveness of Capefcitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on insentive chemotherapy
Safety,Efficacy
Confirmatory
Phase II
Progression-free survival
Response Rate(RECIST)
Disease controle rate
Overall survival
Adverse effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Capevitabine plus Bevacizumab therapy
day1 : bevacizumab d.i.v.
day1 to 15 : Capecitabine p.o.
day16 to 21 : Capecitabine rest
repeat every 21 days
65 | years-old | <= |
Not applicable |
Male and Female
1) histologically proven colon cancer or rectal cancer
2) with mesurable lesions for RECIST criteria
3) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before)
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
5) rest period from former therapy
a) more than 4 weeks from an organ resection surgery
b) more than 4 weeks from hormone therapy or immune therapy
c) more than 4 weeks from cytocain or BRM therapy
6) without any severe complications and limited in the following data
a) neutrophile : 1,500/mm3 <=
b) hemoglobin : 9.0g/dl <=
c) platelet : 100,000/mm3 <=
d) T.bil. : 1.5mg/dl >=
e) AST, ALT : within 2.5 times of normal range of the hospital
f) creatinine : 1.2mg/dl >=
g) creatinine clearance >=30mL/min
male : [(140-age) x B.W.(kg)]/[72 x s-creatinine(mg/dl)]
female : [(140-age) x B.W(kg) x 0.85]/[0.72 x s-creatinine(mg/dl)]
7) patients expected more than 8 weeks survival
8) with written Informed Consent
9) age :
Group E : >= 76 years old
Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events
1) with symptoms due to brain metastatis
2) with uncontrolable diarrhea
3) with difficulty on oral intake due to intestinal paralysis or obstruction
4) with infections diseases or febrile condition
5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc)
6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure)
7) pregnant and/or nursing women, or women who expect pregnancy
8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder
9) with a grade 3 neural disorder
10) with a condition intlerance to
medicines in this regimen
11) with a history of grade 3 allergy against Capecitabine
12) with a history of some chemotherapy and/or therapy including a VEGF antagonist
13) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction
14) under easy bleeding condition due to some diseases or medicines (except low dose aspirin)
15) with a history of thoracic surgery of abdominal surgery 28 days ago
16) with active wounds except reservoir surgery
17) with a history of bloody spit more than 2.5ml
18) any other patient whom the physician in charge of the study judges to be unsuitable
30
1st name | |
Middle name | |
Last name | Motoki Yoshida |
Osaka Medical College Hospital
chemotherapy center
2-7,Daigakutyou,Takatsuk,City,Osaka
072-683-1221
motoyoshi@krmc.or.jp
1st name | |
Middle name | |
Last name | Hiroshi Furukawa |
Kinki University School of Medicine
Department of surgery
377-2, Onohigashi, Osakasayama, Osaka, Japan
072-366-0221
hiroshi.furukawa@tokushukai.jp
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Osaka Clinical Study Supporting Organization
Self funding
NO
大阪医科大学(大阪府)、大阪市立総合医療センター(大阪府)、関西医科大学付属病院(大阪府)、関西労災病院(兵庫県)、慈泉会相澤病院(長野県)、大阪府立成人病センター(大阪府)、市立岸和田市民病院(大阪府)、市立貝塚病院(大阪府)、西宮市立中央病院(兵庫県)、まちだ胃腸病院(大阪府)
2011 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 01 | Month | 21 | Day |
2011 | Year | 05 | Month | 02 | Day |
2011 | Year | 07 | Month | 04 | Day |
2016 | Year | 07 | Month | 31 | Day |
2016 | Year | 11 | Month | 21 | Day |
2011 | Year | 03 | Month | 07 | Day |
2020 | Year | 09 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006142
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