UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035401 |
|---|---|
| Receipt number | R000040337 |
| Scientific Title | AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2018/12/29 |
| Last modified on | 2024/05/07 09:19:02 |
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Basic information
Public title
AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer
Acronym
Randomized phase 2 of CDDP and PEM or S-1 plus Bev
Scientific Title
AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer
Scientific Title:Acronym
Randomized phase 2 of CDDP and PEM or S-1 plus Bev
Region
| Japan |
Condition
Condition
Advanced non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted a randomized phase II trial comparing first-line S-1 plus cisplatin with bevacizumab and pemetrexed plus cisplatin with bevacizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC), and comare the safety and efficacy both regimens.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
overall survival, overal response rate, time to treatment failure, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cisplatin+S-1+Bev
Interventions/Control_2
Cisplatin+PEM+Bev
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
Eligible patients were required to have: histologically and/or cytologically proven unresectable stage IIIB or IV non-squamous NSCLC; no previous chemotherapy or radiotherapy; a performance status (PS) of 0-1 on the Eastern Cooperative Oncology Group; an age between 20 years and 74 years; a life expectancy of 12 weeks or more; adequate bone marrow reserve (leukocyte count > 4000 mm-3, neutrophil count > 2000 mm-3, platelet count > 100000 mm-3, and hemoglobin > 10 g dL-1); normal liver function (total serum bilirubin < 1.5 mg dL-1, and aspartate transaminase (AST), alanine transaminase (ALT) less than twice the upper limit of the normal range), normal renal function (normal serum creatinine and blood urea nitrogen levels) and pulmonary function (PaO2 > 70 torr).
Signed informed consent
Key exclusion criteria
Patients were excluded if they had malignant pleural or pericardial effusion, active double cancer, a concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction in the previous 3 months, heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension, interstitial pneumonia or lung disease, infection or other diseases contraindicating chemotherapy or radiotherapy, pregnancy, or breast-feeding.
Judging of inappropriate condition for this study by physian
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-39-15, showa-machi, Maebashi, Gunma, 371-8511, Japan
TEL
027-220-7111
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-39-15, showa-machi, Maebashi, Gunma, 371-8511, Japan
TEL
027-220-7111
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2018 | Year | 12 | Month | 29 | 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
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040337
