UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020439 |
|---|---|
| Receipt number | 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 | 2023/01/13 13:55:36 |
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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 | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
052-762-6111
h.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Masuishi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
052-762-6111
Homepage URL
tmasuishi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
Tel
0527626111
irb-jimu@aichi-cc.jp
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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
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
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023602
