UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

watanabe.naoki@kagawa-u.ac.jp

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

watanabe.naoki@kagawa-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

18

Day

Last modified on

2021

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027249