Unique ID issued by UMIN | UMIN000015405 |
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Receipt number | R000017596 |
Scientific Title | A randomized, phase III trial of sequential capecitabine/5FU plus bevacizumab (Cape/5FU-Bmab) to capecitabine/5FU plus oxaliplatin plus bevacizumab (CapeOX/mFOLFOX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer. |
Date of disclosure of the study information | 2014/10/14 |
Last modified on | 2019/02/22 13:07:56 |
A randomized, phase III trial of sequential capecitabine/5FU plus bevacizumab (Cape/5FU-Bmab) to capecitabine/5FU plus oxaliplatin plus bevacizumab (CapeOX/mFOLFOX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer.
C Cubed Study (JSWOG C-4)
A randomized, phase III trial of sequential capecitabine/5FU plus bevacizumab (Cape/5FU-Bmab) to capecitabine/5FU plus oxaliplatin plus bevacizumab (CapeOX/mFOLFOX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer.
C Cubed Study (JSWOG C-4)
Japan |
advanced and/or recurrent colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
YES
To evaluate the superiority of capecitabine (or LV5FU2) + bevacizumab followed by XELOX (or FOLFOX) + bevacizumab compared to XELOX (or FOLFOX) + bevacizumab as first-line treatment in metastatic colorectal carcinoma.
Safety,Efficacy
Exploratory
Pragmatic
Phase III
Time to Failure of Strategy
Progression free-survival,Overall survival, Quality of Life,Overall response rate (ORR),Time to treatment-failure, Duration of disease control, Safety
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
XELOX(or FOLFOX)+Bevacizumab is given until disease progression.
Capecitabine (or LV5FU2)+Bevacizumab is given until disease progression. After progression, XELOX(or FOLFOX)+Bevacizumab is given until disease progression.
20 | years-old | <= |
Not applicable |
Male and Female
1) Histopathologically confirmed colorectal cancer
2) Advanced or recurrent colorectal cancer who are not candidate for curative resection
(1)Patients with advanced colorectal cancer who had received no intervention expect surgical procedure(R0 surgery is not included).
(2)Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site. (six months after Adjuvant is not included).
3) Age of 20 years or older
4) ECOG performance status of 0-2
5) Presence of evaluable lesions as confi rmed by CT or MRI; no previous chemo therapy or radiotherapy
6) Life expectancy longer than 90 days
7) Oral administration is possible
8) Adequate organ function according to following laboratory values obtained within 14 days before enrolment (Data recorded nearest to the entry should be referred. And excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
Neu >=1,500/mm3
Pt >=10.0*10^4 /mm3
Hb >=8.0 g/dL
T-bil <=2.0mg/dl
AST and ALT <=100IU/l (Liver metastasis =< 200IU/l)
sCr <=Institution standard value*1.5
Ccr >=30mL/min(Cockcroft-Gault)
Proteinuria <=1+
PT- INR <3.0
9) Written informed consent after receiving explanation of planned treatments in the study
1) History of active double cancer within 5 years
2) History of serious drug hypersensitivity or serious drug allergy.
3) Sever renal failure, hematologic toxicities, diarrhea, infections, massive pleural effusion, peritoneal fluid
4) Sever or uncontrolled complications (diabetes mellitus, High blood pressure, diarrhea, abnormality of the electrolyte).
5) Complication of cerebrovascular disease or the symptoms within 1 year
6) Bleeding tendency, coagulopathy (PT-INR>=3.0 within 1week prior to entry)
7) Thrombosis, thromboembolism, or receiving anticoagulant drugs (except aspirin under 325 mg/day)
8) Unhealed wound, or major surgical procedure within 28 days prior to enrollment in the study
9) Invasive assessment within 7 days prior to enrollment in the study excluding regular blood sampling, drip infusion, endoscopic examination, and central port
10) Aortic aneurysm and aortic dissection
11) Uncontrollable peptic ulcer
12) Concurrent or history of gastrointestinal perforation (within 1 year before enrollment)
13) Untreated traumatic bone fracture
14) Uncontrolled hypertension
15) Peripheral neuropathy >=Grade1
16) Patients who are pregnant, lactating, with child-bearing potential or have no intention to use contraceptive measures.
17) History of adverse events related to DPD deficiency
18) Mental disorders or central nervous system disease which could hinder treatments of the study
19) Patients who is judged by the investigator to be inappropriate for study participation for any reason.
*Data recorded nearest to the entry should be referred.
304
1st name | |
Middle name | |
Last name | Yoshiyuki Yamaguchi |
Kawasaki Medical School
Department of Clinical Oncology
577 matsushima Kurashiki city Okayama Japan
086-462-1111
shogo@med.kawasaki-m.ac.jp
1st name | |
Middle name | |
Last name | Morihiro Fujita |
NPO Japan Southwest Oncology Research Support Organization
Study Secretariat
14-19-602 Nobori-cho Naka-ku Hiroshima Japan
082-222-1350
office@jswog.org
NPO Japan Southwest Oncology Research Support Organization
CHUGAI PHARMACEUTICAL CO.,LTD
Profit organization
NO
2014 | Year | 10 | Month | 14 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 28 | Day |
2014 | Year | 12 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 11 | Month | 06 | Day |
2019 | Year | 02 | Month | 22 | Day |
2014 | Year | 10 | Month | 10 | Day |
2019 | Year | 02 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017596
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