UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.
Title of the study (Brief title)	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	Seigo Minami
Organization	Osaka Police Hospital
Division name	Dept. of Respiratory Medicine
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	Seigo Minami
Organization	Osaka Police Hospital
Division name	Dept. of Respiratory Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019029