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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024899
Receipt No. R000027249
Scientific Title A multicenter, open-label, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in non-small cell lung cancer patients receiving docetaxel/ramucirumab chemotherapy
Date of disclosure of the study information 2016/11/21
Last modified on 2019/07/06

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Basic information
Public title A multicenter, open-label, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in non-small cell lung cancer patients receiving docetaxel/ramucirumab chemotherapy
Acronym Pegfilgrastim to reduce the risk of FN in NSCLC patients receiving docetaxel/ramucirumab chemotherapy
Scientific Title A multicenter, open-label, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in non-small cell lung cancer patients receiving docetaxel/ramucirumab chemotherapy
Scientific Title:Acronym Pegfilgrastim to reduce the risk of FN in NSCLC patients receiving docetaxel/ramucirumab chemotherapy
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of pegfilgrastim prophylaxis in combination therapy of docetaxel and ramucirumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes incidence of febrile neutropenia during the first cycle of treatment
Key secondary outcomes Lowest white blood cell count, Lowest neutrophilic count, Days to febrile neutropenia, Days to a neutropenia to recovery, Adverse events, Severe adverse events, Association with the previously treated regimen

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 pegfilgrastim non-use group(daily use of G-CSF is permitted at the time of grade 4 neutropenia or febrile neutropenia)
Interventions/Control_2 pegfilgrastim use group
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 or cytologically proved non-small cell lung cancer
2)Relapse or a case considered no surgical indication
3)ECOG Performance Status 0-2
4)Scheduled to be the combination therapy of docetaxel and ramucirumab
5)Meets the following criteria within 7days before enrollment
hemoglobin: >=9 g/dL
absolute neutrophil: >=1500/mm3
white blood cell count: >=3000/mm3
platelet count: >=100,000/mm3
AST and ALT: <=2.5 X ULN
total bilirubin: <=1.5mg/dL
PaO2: >=60mmHg or SpO2: >=90%(Room air)
6)Written informed consent to participate in this study
Key exclusion criteria 1)Patients must not have any allergy with G-CSF in the past
2)Pregnant or nursing women
3)Tumor invasive to the chest large blood vessel, Cavity in lung tumor
4)Serious complications (heart failure, celebrovascular disorder, or active peptic ulcer etc)
5)History of hemoptysis with 2.5mL or more and Continued bloody phlegm
6)Evidence of bleeding diathesis or coagulopathy
7)Uncontrolled mental disease
8)Uncontrolled hypertension
9)Uncontrolled diabetes
10)Uncontrolled infectious disease
11)Patients with myelodysplastic syndrome or aplastic anemia
12)Double cancer in need of treatment
13)Planned radiation therapy
14)Patients were judged unqualified for this study by attending physician
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Watanabe
Organization Kagawa University
Division name Department of Internal Medicine, Hematology, Rheumatology and Respiratory Medicine
Zip code 7610701
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL 087-891-2145
Email naoki-w@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Watanabe
Organization Kagawa University
Division name Department of Internal Medicine, Hematology, Rheumatology and Respiratory Medicine
Zip code 7610701
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL 087-891-2145
Homepage URL
Email naoki-w@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa Universit, Department of Internal Medicine, Hematology, Rheumatology and Respiratory Medicine
Institute
Department

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 Kagawa University Clinical Research Support Center
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel 087-898-5111
Email chiken@med.kagawa-u.ac.jp

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
2016 Year 11 Month 21 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 10 Day
Date of IRB
2016 Year 11 Month 18 Day
Anticipated trial start date
2016 Year 11 Month 21 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 18 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027249

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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