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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016383
Receipt No. R000019029
Scientific Title Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.
Date of disclosure of the study information 2015/02/02
Last modified on 2016/08/05

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Basic information
Public title Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.
Acronym OPH-RM-LC-1501
Scientific Title Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.
Scientific Title:Acronym OPH-RM-LC-1501
Region
Japan

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

Objectives
Narrative objectives1 Primary prophylaxis with pegfilgrastim is expected to reduce occurrence of febrile neutropenia during docetaxel monotherapy. The reduction of febrile neutropenia and severe neutropenia potentially lead to preservation of dose intensity of docetaxel and improvement of treatment efficacy. The aim of this study is to evaluate an effect of pegfilgrastim to improve treatment efficacy of docetaxel monotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Response rate, Overall survival, Frequency of febrile neutropenia, Frequency of Grade 4 neutropenia, Adverse effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Addition of primary prophylaxis with pegfilgrastim to docetaxel monotherapy
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 or cytologically confirmed non-small cell lung cancer
2) Stage III / IV or recurrence after surgery, without any indications for radiotherapy or surgery
3) Evaluable disease (RECIST ver1.1)
4) Progressive disease or recurrence after platinum-containing chemotherapy
Pre-treated with EGFR-TKI in patients with active EGFR mutation.
Pre-treated with ALK inhibitor in ALK-positive patient
Adjuvant platinum-containing chemotherapy was considered as one regimen.
Interval; two week after thoracic radiotherapy
5) Age over 20 year-old
6) ECOG Performance status 0-2
7) Adequate organ function, evaluated within 14 days before enrollment
8) Expected 3 month survival
9) Written informed consent
Key exclusion criteria (1) A history of docetaxel treatment
(2)Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest X-ray film
(3)Concurrent thoracic radiotherapy
(4) A history of severe hypersensitivity against docetaxel or pegfilgrastim
(5)Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer
(6)Pleural effusion, ascites or peri-cardiac effusion requiring dranage.
(7)Problematic complications
(8) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(9) Decision of ineligibility by a physician
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Minami
Organization Osaka Police Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL 06-6771-6051
Email seigominami@oph.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seigo Minami
Organization Osaka Police Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL 06-6771-6051
Homepage URL
Email seigominami@oph.gr.jp

Sponsor
Institute Dept. Respiratory Medicine, Osaka Police Hopital
Institute
Department

Funding Source
Organization Dept. Respiratory Medicine, Osaka Police Hopital
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 大阪警察病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 02 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
2014 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 02 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
2015 Year 01 Month 30 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019029

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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