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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009870
Receipt No. 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

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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
Email 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
Email kuroda-k@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011563

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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