UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of carboplatin/pemetrexed/bevacizumab for non-squamous NSCLC with carcinomatous pleuritis (NEJ013A)
Title of the study (Brief title)	Phase II of CBDCA/PEM/BEV for NSCLC with carcinomatous pleuritis
Region	Japan

Condition
Condition	Non-small cell lung cancer (non-squamous cell carcinoma)
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of CBDCA/PEM/BEV for NSCLC with carcinomatous pleuritis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of controlled pleural effusion at 8 weeks
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	carboplatin/pemetrexed/bevacizumab
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. Pathologically confirmed NSCLC (non-squamous cell carcinoma) 2. Clinical stage IV or post-operative recurrence 3. Massive pleural effusion including malignant cells that requires tube drainage. 4. Chemotherapy naive except for EGFR-TKI 5. Aged over 20 years old with performance status 0-2 6. With addequate organ functions 7. With written informed consent
Key exclusion criteria	1. Clinically ineligible interstitial pneumonitis 2. Episode of hemoptysis 3. With brain metastasis, or tumor with large vessel invation or cavity formation 4. With active gastrointestinal ulcer 5. With severe comorbidities 6. With inadequate conditions judged by the attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuhiro Usui
Organization	Kanto Medical Center NTT-EC
Division name	Division of Respirology and Chest Surgery
Address	5-9-2, Higashi-gotanda, Shinagawa-ku, Tokyo
TEL	03-3448-6111
Email	usui@east.ntt.co.jp

Public contact
Name of contact person	Kazuhiro Usui
Organization	Kanto Medical Center NTT-EC
Division name	Division of Respirology and Chest Surgery
Address	5-9-2, Higashi-gotanda, Shinagawa-ku, Tokyo
TEL	03-3448-6111
Homepage URL
Email	usui@east.ntt.co.jp

Sponsor
Institute	North-East Japan study group
Institute
Department

Funding Source
Organization	North-East Japan study group
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

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 29 Day
Anticipated trial start date	2011 Year 10 Month 01 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	2011 Year 08 Month 29 Day
Last modified on	2016 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007388