Unique ID issued by UMIN | UMIN000005732 |
---|---|
Receipt number | R000006695 |
Scientific Title | Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial |
Date of disclosure of the study information | 2011/06/07 |
Last modified on | 2011/06/07 10:33:54 |
Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial
Phase II clinical trial using capecitabine plus intermittent oxaliplatin together with Bevacizumab for the treatment of patients with advanced colorectal cancer (VOICE trial)
Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial
Phase II clinical trial using capecitabine plus intermittent oxaliplatin together with Bevacizumab for the treatment of patients with advanced colorectal cancer (VOICE trial)
Japan |
advanced colorectal cancer
Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To access the efficacy and safety of the combination of intermittent CapeOx + Bevacizumab as a first-line therapy in patients with advanced colorectal cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
progression free survival (PFS)
Safety
time-to-treatment failure
response rate 1 (RR 1)
progression free survival 2 (PFS 2)
response rate 2 (RR 2)
resection rate in
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
capecitabine plus intermittent oxaliplatin (CapeOx) in combination with Bevacizumab: (CapeOx + Bevacizumab)x5 cycles followed by (Capecitabine + Bevacizumab )x5 cycles, followed by (CapeOx + Bevacizumab)x5 cycles are administered until progression.
[CapeOx + Bevacizumab]
Capecitabine: 2000mg/m2/day p.o. (day1-15)
Oxaliplatin: 130mg/m2 i.v. (day1)
Bevacizumab: 7.5mg/kg i.v. (day1)
to be repeated every 3 weeks
[Capecitabine + Bevacizumab]
Capecitabine: 2000mg/m2/day p.o. (day1-15)
Bevacizumab: 7.5mg/kg i.v. (day1)
to be repeated every 3 weeks
20 | years-old | <= |
Not applicable |
Male and Female
(1)Written informed consent.
(2)20 years old or more when received informed consent.
(3)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):0-1.
(4)Life expectancy estimated 3 months, and more.
(5)Histological confirmation of colorectal cancer.
(6)With estimative lesion observed in imaging or intraoperation within 28 days before registration. (measurable lesions in RECIST criteria [ver.1.1] is dispensable)
(7)Patients with metastatic colorectal cancer who had recieved no previous therapy.
Patients with advanced colorectal cancer who had received no intervention expect surgical procedure.
Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site.
(8)Patients who received no previous chemotherapy
i.Patients who administered curative resection for primary or metastatic site with perioperative chemotherapy is excluded.
ii.Patients who received non-curative resection is included.
iii.Previous treatment with oxaliplatin contained regimen is allowed if it is completed at least 6 months before registration.
(9)Vital organ functions (listed below) are preserved within 14 days prior to entry.
i.White blood cell count >= 3,000/mm3
ii.Neutrophils >= 1,500/mm3
iii.Platelets >= 100,000/mm3
iv.Hemoglobin >= 9.0 g/dL
v.Total bilirubin <= upper limit of normal (ULN)*1.5
vi.AST and ALT <= upper limit of normal (ULN)*2.5
(<= ULN*5 in case of liver metastasis)
vii.Serum creatinine <= upper limit of normal (ULN)*1.5
viii.Urinary protein <= grade1 (+1)
(1)History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab.
(2)CNS metastases or brain cancer confirmed by imaging.
(3)Cerebrovascular disease or its symptoms within 1 year. Prior abdominal irradiation for colorectal cancer. History of suspected complication of arterial thromboembolism such as cerebrovascular disease or experienced thromboembolism once within a year or twice bore.
(4)History of gastrointestinal perforation within 1 year.
(5)Synchronous malignant coelomic fluid that required drainage.
(6)Uncontrolled peptic ulcer.
(7)Uncontrolled diarrhea.
(8)Uncontrolled infection.
(9)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor as INR>=1.5.
(10)Uncontrolled hypertension.
(11)Necessity for antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 14 days before enrollment(Expect for low-dose of aspirin).
(12)History of active double cancer within 5 years.
(13)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(14)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week.
(15)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(16)Not appropriate for the study at the physician's assessment.
50
1st name | |
Middle name | |
Last name | Keiji Koda |
Teikyo University Chiba Medical Center
Department of Surgery
3426-3 Anesaki, Ichihara City, 2990111 Japan
0436-62-1211
1st name | |
Middle name | |
Last name | Chihiro Kosugi and Toru Tezuka |
Teikyo University Chiba Medical Center
Department of Surgery
3426-3 Anesaki, Ichihara City, 2990111 Japan
043-293-0086
ckosugi0126@yahoo.co.jp
Surgical Oncology Association in Chiba (SOAC)
Surgical Oncology Association in Chiba (SOAC)
Non profit foundation
Japan
NO
プロトコール委員会
帝京大学ちば総合医療センター 外科
千葉大学医学部 先端応用外科学
東邦大学医療センター佐倉病院 外科
成田日赤病院 外科
君津中央病院 外科
聖隷佐倉市民病院 外科
千葉県がんセンター 消化器内科
亀田総合病院 腫瘍内科
船橋中央病院 外科
船橋市立医療センター 外科
2011 | Year | 06 | Month | 07 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2011 | Year | 06 | Month | 07 | Day |
2011 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006695
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |