UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026927 |
|---|---|
| Receipt number | 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 10:49:31 |
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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
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
yteppei@aichi-cc.jp
Sponsor or person
Institute
Central Japan Lung Study Group (CJLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030233
| Research Plan | |
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