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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020439
Receipt No. R000023602
Scientific Title A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.
Date of disclosure of the study information 2016/01/05
Last modified on 2016/01/05

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Basic information
Public title A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.
Acronym A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.
Scientific Title A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.
Scientific Title:Acronym A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of alternate-day administration of S-1 and oral leucovorin in combination with oxaliplatin and bevacizumab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate as assessed by independent ragiologic review
Key secondary outcomes Objective response rate as assessed by investigators
Progression free survival
Time to treatment failure
Overall survival
Disease control rate
The efficacy according to RAS status
R0 resection rate
Safety
Relative dose intensity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 80-120 (mg/day) Monday, Wednesday, Friday, Sunday
Leucovorin 50 (mg/day) Monday, Wednesday, Friday, Sunday
Oxaliplatin 85 (mg/m2) day1
Bevacizumab 5 (mg/kg) day 1
every 2 weeks
Interventions/Control_2
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) Histologically proven adenocarcinoma of unresectable colorectal cancer
(2) With measurable disease according to RECIST version1.1
(3) No prior chemotherapy
(4) ECOG Performance Status of 0 or 1
(5) >=20 years old
(6) Life expectancy of more than 3 months
(7) Adequate oral intake
(8) Adequate organ function
(9) Written informed consent
Key exclusion criteria (1) Active multiple malignancy
(2) History of severe drug-induced hypersensitivity
(3) Symptomatic brain metastasis
(4) Active infection
(5) Interstitial pneumonia or pulmonary fibrosis
(6) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus)
(7) massive pleural, abdominal, or pericardial effusion
(8) Administration of phenytoin or flucytosine
(9) Systemic administration of steroid
(10) Thromboembolism (grade 3 or higher) within 6 months before enrollment
(11) Any major surgery or open biopsy within 4 weeks before scheduled date of treatment
(14) Bleeding diathesis or tendency
(13) Active peptic ulcer
(14) History of gastrointestinal perforation within 1 year before enrollment
(15) Clinically significant mental disorder
(16) Positive for HBs antigen
(17) Women who are pregnant or patients who are unwilling to avoid pregnancy
(18) grade 2 or higher peripheral neuropathy
(19) previous treatment with oxaliplatin
(20) Patients who are inappropriate for the study in the opinion of the investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Taniguchi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Email h.taniguchi@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Masuishi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Homepage URL
Email tmasuishi@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 01 Month 05 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 05 Day
Last modified on
2016 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023602

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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