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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027223
Receipt No. R000031172
Scientific Title A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2017/05/08
Last modified on 2018/12/27

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Basic information
Public title A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Acronym A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Scientific Title A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Scientific Title:Acronym A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of febrile neutropenia during all cycles of ramucirumab plus docetaxel therapy
Key secondary outcomes Response rate
Overall survival
Progression free survival
Adverse events

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 Add pegfilgrastim to docetaxel plus ramcirumab treatment as primary prophylaxis
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 and/or cytologically proven non-small cell lung cancer
2)Previously treated non-small cell lung cancer, with stage III of unsuitable for radiotherapy, stage IV and recurrent disease
3)Patients who have treated with at least one cytotoxic chemotherapy
(In patients with driver mutations such as EGFR mutation or ALK rearrangement, tyrosine kinase inhibitor treatement is required before enrolling this study.)
4)Have measurable lesion
5)Must be 20 or more years old at the time of consent
6)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
7)Have adequate organ function within two week before study entry
8)Estimated life expectancy of at least 12 weeks
9)Have signed an informed consent document
Key exclusion criteria 1)Interstitial pneumonia , fibroid lung confirmed by CT.
2)History of serious drug allergy
3)Patient with much ascetic fluid, pleural effusion, cardiac effusion.
4)Obvious tumor invasion to main thoracic vessel
5)Have lung cavity
6)Histoly of hemoptysis within two months
7)History of thoracic radiation therapy
8)Tumor invasion to central airway
9)Uncontrolled coagulation disorder or receiving anticoagulant drugs
10)Have inflammatory bowel disease
11)History of thrombosis
12)Have active wounds
13)Uncontrollable hypertension
14)Proteinuria
15)Patient with active infection
16)Symptomatic brain metastases
17)Patient with active double cancers
18)Have active severe heart diseases
19)Patient with impaired mental status
20)Pregnancy
21)Other ineligible status judged by attending doctor
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoya Kawaguchi
Organization Osaka City University
Division name Department of Respiratory Medicine
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3793
Email kawaguchi.tomoya@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Sawa
Organization Osaka City University
Division name Department of Respiratory Medicine
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3793
Homepage URL
Email sawa.kenji@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Department of Respiratory Medicine
Institute
Department

Funding Source
Organization Osaka City University
Department of Respiratory Medicine
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
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 大阪市立大学医学部附属病院(大阪府)
ベルランド総合病院

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 08 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
2017 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 08 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
2017 Year 05 Month 02 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031172

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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