UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026927
Receipt No. R000030233
Scientific Title A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602)
Date of disclosure of the study information 2017/04/10
Last modified on 2019/03/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602)
Acronym Observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel
Scientific Title A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602)
Scientific Title:Acronym Observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of pegfilgrastim during ramucirumab plus docetaxel therapy
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 1) Incidence of febrile neutropenia during the first cycle of chemotherapy
2) Incidence of G4 neutropenia during the first cycle of chemotherapy
3) Incidence of G4 neutropenia during the all cycles of chemotherapy
4) Response rate
5) Relative dose intensity
6) Adverse events

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Histology/cytology-proven non-small cell lung cancer
2) Previously treated non-small cell lung cancer with stage III, IV or recurrent disease
3) Patient previously treated with at least two regimens of chemotherapy
*It does not count as one regimen; treatment with PD-1/PD-L1 checkpoint inhibitors, anti-CTLA-4, EGFR-TKIs in patients with EGFR-mutated patients, ALK-TKIs in patients with ALK-positive patients, ROS-1-TKIs in patients with ROS-1-positive patients.
*Recurrence within 6 months or less from the day adjuvant chemotherapy finished is considered a previous treatment.
4) Age of 70 years or over
5) Patients who are considered to survive for more than 3 months
6) Written informed consent
7) ECOG performance status of 0-2
8) Adequate organ function.
Key exclusion criteria 1) Active infection
2) Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment)
3) Evidence of tumor invading a perihilar blood vessel
4) Having a cavitating lung tumor
5) History of pulmonary hemorrhage or hemoptysis over 2.5 ml within 2 months
6) Evidence of tumor invading segmental bronchus
7) Severe gastrointestinal complications
8) Having a history or evidence of thrombosis
9) Severe hypertension
10) Having a history or evidence of ILD complication
11) Having an allergy of ramucirumab, docetaxel and pegfilgrastim
12) Having a severe mental disorder
13) Pregnant woman
14) Patients whose participation in the trial is judged to be inappropriate by the doctor
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Imaizumi
Organization Fujita Health University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL 0562-93-9241
Email jeanluc@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Yamaguchi
Organization Aichi Cancer Center Hospital
Division name Department of Thoracic Oncology
Zip code
Address 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL 052-762-6111
Homepage URL
Email yteppei@aichi-cc.jp

Sponsor
Institute Central Japan Lung Study Group (CJLSG)
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 10 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 Completed
Date of protocol fixation
2017 Year 02 Month 27 Day
Date of IRB
2017 Year 02 Month 27 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2018 Year 11 Month 06 Day
Date of closure to data entry
2019 Year 03 Month 15 Day
Date trial data considered complete
2019 Year 03 Month 15 Day
Date analysis concluded
2019 Year 03 Month 15 Day

Other
Other related information To evaluate the efficacy and safety of pegfilgrastim during ramucirumab plus docetaxel therapy

Management information
Registered date
2017 Year 04 Month 10 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.