Unique ID issued by UMIN | UMIN000004971 |
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Receipt number | R000004978 |
Scientific Title | Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer |
Date of disclosure of the study information | 2011/01/27 |
Last modified on | 2015/07/28 19:14:19 |
Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer
KPUMDS C-01 STUDY
Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer
KPUMDS C-01 STUDY
Japan |
advanced and recurrent colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and the safety of XELOX/Bevacizumab as a first line chemotherapy for the patients with advanced or recurrent colorectal
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
Overall response rate
Progression-free survival
Time to treatment-failure
Liver resection rate
Liver R0 resection rate
Safety
Efficacy according to K-ras status (RR,PFS,TTF,Liver resection rate,Liver R0 resection rate,Safety)
RR according to smorking habit
PFS of bevacizumab-related hypertension with or without
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oxaliplatin 130mg/m2 i.v.(day1)
Bevacizumab 7.5mg/kg i.v.(day1) Capecitabine 2000mg/m2 p.o.(day1-14)
to be repeated every 3weeks
Not applicable |
Not applicable |
Male and Female
1)Patients with pathologically proven colorectal cancer (adenocarcinoma)
2)No prior treatment for advanced and recurrent colorectal cancer
3)With bevacizumab plus XELOX
4)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
5)Performance Status:0-1 (ECOG)
6)Written informed consent is taken
7)Required baseline laboratory parameters (within one week before registration)
1.neutrophils>=1,500/mm3
2.platelets>=100,000/mm3
3.hemoglobin>=9.0g/dL
4.T-Bil within 1.5 times of normal limit of each hospital
5.AST,ALT,ALP within 2.5 times of normal limit of each hospital(in case of hepatic metastatic patients are within 5.0 times of normal limit )
6.Cre within 1.5 times of normal limit of each hospital
8)Creatinine clearance<=50ml/min
1)Contraindication of bevacizumab oxaliplatin and capecitabine
2)Brain tumors or brain metastasis
3)Presence of cerebrovascular disease or symptoms less than 1 year prior to entry
4)Any surgical treatments oncluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
5)Non-healing bone fracture
6)Uncontrolled peptic ulcer
7)Uncontrolled hypertension
8)the internal organ transplant
9)Interstitial pneumonitis, pulmonary fibrosis
10)Uncontrolled Infection
11)Renal failure to be treated, 1+ or higher proteinuria within 1 weeks prior to entry
12)History of adverse events related to DPD loss
13)Daily treatment wit high-dose aspirin (>=325/day) or non-steroidal anti-inflammatory medications
14)Pregnant women, nursing mothers, possibly pregnant women
15)Perforation of gastrointestinal tract less than 1 year prior to entry
16)Clinically significant (i.e. active) cardiovascular disease (>= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 4), clinically important echocardiographic findigs, or past or current history (within the last 1 year) of myocardial infarction
17)Peripheral neuropathy of at least grade 1
18)Uncontrolled pleural and/or peritoneal effusion
19)Not appropriate for the study at the physician's assessment
100
1st name | |
Middle name | |
Last name | Eigo Otsuji |
Kyoto Prefectural University of Medicine
Digestive Surgery
465 Kajii-cho Kawaramachi-dori Hirokoji Kamigyo-ku Kyoto Japan 602-8566
075-251-5527
otsuji@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Masayoshi Nakanishi |
Kyoto Prefectural University of Medicine
Digestive Surgery
465 Kajii-cho Kawaramachi-dori Hirokoji Kamigyo-ku Kyoto Japan 602-8566
075-251-5527
mnakan@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Kyoto Prefectural University of Medicine
Self funding
NO
2011 | Year | 01 | Month | 27 | Day |
Partially published
Completed
2010 | Year | 03 | Month | 24 | Day |
2010 | Year | 04 | Month | 01 | Day |
2011 | Year | 01 | Month | 27 | Day |
2015 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004978
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