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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015405
Receipt No. 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

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Basic information
Public 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.
Acronym C Cubed Study (JSWOG C-4)
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.
Scientific Title:Acronym C Cubed Study (JSWOG C-4)
Region
Japan

Condition
Condition advanced and/or recurrent colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Time to Failure of Strategy
Key secondary outcomes Progression free-survival,Overall survival, Quality of Life,Overall response rate (ORR),Time to treatment-failure, Duration of disease control, Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 XELOX(or FOLFOX)+Bevacizumab is given until disease progression.
Interventions/Control_2 Capecitabine (or LV5FU2)+Bevacizumab is given until disease progression. After progression, XELOX(or FOLFOX)+Bevacizumab is given until disease progression.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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

Key exclusion criteria 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.
Target sample size 304

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Yamaguchi
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address 577 matsushima Kurashiki city Okayama Japan
TEL 086-462-1111
Email shogo@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morihiro Fujita
Organization NPO Japan Southwest Oncology Research Support Organization
Division name Study Secretariat
Zip code
Address 14-19-602 Nobori-cho Naka-ku Hiroshima Japan
TEL 082-222-1350
Homepage URL
Email office@jswog.org

Sponsor
Institute NPO Japan Southwest Oncology Research Support Organization
Institute
Department

Funding Source
Organization CHUGAI PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 11 Month 06 Day
Date trial data considered complete
2019 Year 02 Month 22 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 10 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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