UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia
Title of the study (Brief title)	Phase II study of Pemetrexed + Carboplatin for lung cancer with interstitial pneumonia
Region	Japan

Condition
Condition	no-small and non-squamous lung cancer with interstitial penumonia
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of carboplatin and pemetrexed combination therapy for non-small and non-squamous lung cancer with interstitial pneumonia
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The frequency of severe lung injury on 28 days after the last chemotherapy
Key secondary outcomes	Response rate, disease control rate, overall survival and progression free survival

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	Pemetrexed and carboplatin combination therapy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Non-small and non-squamous lung cancer 2) Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT 3) No indication of radiation therapy and surgical resection 4) Chemotherapy naive patients 5) Age over 20 -79 years 6) ECOG Performance status 0-1 7) %FVC >= 66% and %DLCO >= 36% for each predictive values within a month of registration 8) Adequate organ function 9) Life expectancy > 3 months 10) Signed informed consent
Key exclusion criteria	1) Having uncontroled infection 2) Having a fever (more than 38 degrees (Celsius)) 3) Having past history of acute exacerbation of interstitial pneumonia 4) Progression of interstitial pneumonia on chest CT within 3 months 5) Over 21mg/day dose of predonisolone 6) Sarcoidosis and collagen vascular diseases 7) Having past history of drug-induced lung injury and radiation pnumonitis 8) Having severe complications 9) Active concomitant malignancy without evidence of recurrence within 5 years 10) Having an uncontrolable pleural effusion 11) Having allergy for pemetrexed or carboplatin 12) History of pregnancy or lactation 13) Decision of ineligibility by the attending physician
Target sample size	25

Research contact person
Name of lead principal investigator	Hiroyuki Taniguchi
Organization	Tosei General Hospital
Division name	Respiratory Medicine and Allergy
Address	160 Nishioiwake-cho, Seto, Aichi
TEL	0561-82-5101
Email	lung@tosei.or.jp

Public contact
Name of contact person	Akira Shiraki
Organization	Ogaki Municipal Hospital
Division name	Respiratory Medicine
Address	4-86 Minaminokawa-cho, Ogaki, Gifu
TEL	0584-81-3341
Homepage URL
Email	akira.shiraki@gmail.com

Sponsor
Institute	Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization	Central Japan Lung Study Group (CJLSG)
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	2013 Year 07 Month 31 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 26 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
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	2013 Year 07 Month 31 Day
Last modified on	2017 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012988