UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of Carboplatin and Pemetrexed for elderly patients with Non-Small Cell (Non Squamous cell)Lung Cancer
Title of the study (Brief title)	A Phase II Study of Carboplatin and Pemetrexed for elderly patients with Non-Small Cell (Non Squamous cell)Lung Cancer
Region	Japan

Condition
Condition	NSCLC non-squamous
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and Efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ORR
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 and Pemetrexed
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically or cytrologically confirmed diagnosis of NSCLC with a adeno or large cell cartinoma. Advanced NSCLC with documented Stage IIIB or Stage IV or recurrent disease. Tumors must have measurable disease by RECIST version 1.1 70 years of age or older. ECOG performance status 0 or 1. No prior systemic treatment for NSCLC. Any major surgery within 4 weeks of study enrollment. No radiotherapy within 2 weeks of study enrollment. No problem adequate organ function.
Key exclusion criteria	Subjects with interstitial pneumonia or pulmonary fibrosis. Uncontrolled Active infection. Subjects with symptomatic brain metastases. Concurrent use of steroid therapy. Uncontrolled pleural. Subjects with previous malignancies. Any other reason that,in the opinion of the investugator precludes the subject from participating in the study.
Target sample size	42

Research contact person
Name of lead principal investigator	Makoto Nishio
Organization	Cancer Institute Hospital of JFCR
Division name	Toracic Medical Oncology
Address	3-8-31,Ariake Koutou-ku Tokyo,Japan
TEL	03-3570-0343
Email	mnishio@jfcr.or.jp

Public contact
Name of contact person	atsushi.horiike@jfcr.or.jp
Organization	Cancer Institute Hospital of JFCR
Division name	Toracic Medical Oncology
Address	3-8-31,Ariake Koutou-ku Tokyo,Japan
TEL	03-3570-0343
Homepage URL
Email	atsushi.horiike@jfcr.or.jp

Sponsor
Institute	Toracic Medical Oncology,Cancer Institute Hospital of JFCR
Institute
Department

Funding Source
Organization	Toracic Medical Oncology,Cancer Institute Hospital of JFCR
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	2010 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 01 Day
Anticipated trial start date	2010 Year 11 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	2010 Year 11 Month 11 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005401