UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014291 |
|---|---|
| Receipt number | R000016644 |
| Scientific Title | Phase II study of combination chemotherapy with cisplatin / pemetrexed / bevacizumab in patients with relapsed nonsquamous non-small cell lung cancer |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/07/24 03:05:07 |
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Basic information
Public title
Phase II study of combination chemotherapy with cisplatin / pemetrexed / bevacizumab in patients with relapsed nonsquamous non-small cell lung cancer
Acronym
SMU Th-R1
Scientific Title
Phase II study of combination chemotherapy with cisplatin / pemetrexed / bevacizumab in patients with relapsed nonsquamous non-small cell lung cancer
Scientific Title:Acronym
SMU Th-R1
Region
| Japan |
Condition
Condition
Relapsed nonsquamous non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and feasibility of of combination chemotherapy with cisplatin(CDDP)/pemetrexed(PEM)/bevacizumab(BEV) in patients with relapsed nonsquamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate, Disease control rate, Overall survival, Toxicity, Disease failure interval
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
isplatin(CDDP)/pemetrexed(PEM)/bevacizumab(BEV)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with relapsed nonsquomouse non-small cell lung cancer
2. Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1
3. one or more sites of measurable disease [per Response Evaluation Criteria in Solid Tumours (RECIST) version 1],
Key exclusion criteria
nervous system metastasis
haemoptysis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Saji |
Organization
St. Marianna University School of Medicine
Division name
Chest Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
+81-44-977-8111
saji-q@ya2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Saji |
Organization
St. Marianna University School of Medicine
Division name
Chest Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
+81-44-977-8111
Homepage URL
saji-q@ya2.so-net.ne.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 07 | Month | 01 | 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
| 2013 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016644
