UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009870 |
|---|---|
| Receipt number | R000011563 |
| Scientific Title | Second line of Avastin and Docetaxel beyond PD by CDDP/PEM/Ava+Ava/PEM for wild and unknown of EGFR/ ALK Non-SQ NSCLC |
| Date of disclosure of the study information | 2013/01/25 |
| Last modified on | 2017/02/04 07:43:30 |
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Basic information
Public title
Second line of Avastin and Docetaxel beyond PD by CDDP/PEM/Ava+Ava/PEM
for wild and unknown of EGFR/ ALK Non-SQ NSCLC
Acronym
SEADOG trial
Scientific Title
Second line of Avastin and Docetaxel beyond PD by CDDP/PEM/Ava+Ava/PEM
for wild and unknown of EGFR/ ALK Non-SQ NSCLC
Scientific Title:Acronym
SEADOG trial
Region
| Japan |
Condition
Condition
wild and unknown of EGFR/ ALK Non-SQ NSCLC
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of the Bevacizumab Beyond Progression (BBP: Second line of Bevacizumab and Docetaxel beyond PD by CDDP/PEM/ Ava+ Ava/ PEM treatment) for the patient with Wild and unknown of EGFR/ ALK Non-SQ NSCLC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
RR for Second line of Bevacizumab and Docetaxel
Key secondary outcomes
PFS, OS, DCR, RR forCDDP/PEM/Ava+Ava/PEM,DCR, safety
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
Avastin and Docetaxel
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
First line
1. Non-SQ stage IIIB or IV or recurrent
2. Wild and unknown of EGFR/ ALK
3. Over age 20 years
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
5. Organ function was tolerated.
Second line
6. CDDP+PEM+BEV treatment was done and judged to be PD after2 cycle of PEM+BEV maintenance at least
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2
8. Organ function was tolerated.
Key exclusion criteria
They had a concurrent malignancy, symptomatic brain metastasis, uncontrollable complications, severe morbidity; hypersensitivity to therapeutic agents; bleeding; the possibility of being pregnant, and other conditions such as hepatic inflammation, as judged by the attending physician.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiro Tanaka |
Organization
University of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
Address
Iseigaoka, Yahatanishi-ku
TEL
093-691-7442
ftanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | koushi kuroda |
Organization
University of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
Address
Iseigaoka, Yahatanishi-ku
TEL
0936917442
Homepage URL
kuroda-k@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
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
産業医科大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 25 | 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
| 2012 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
