UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of pemetrexed + carboplatin followed by maintenance pemetrexed therapy in elderly patients with advanced non-small cell lung cancer
Title of the study (Brief title)	CBDCA+PEM followed by PEM in elderly patients (Phase I/II trial)
Region	Japan

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

Objectives
Narrative objectives1	In phase I trial safety of CBDCA + PEM followed by PEM in eldery patients with NSCLC In phase II trial efficacy of CBDCA + PEM followed by PEM in eldery patients with NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	In phase I trial decision of maximum tolerated dose and recommended dose In phase II trial
Key secondary outcomes	In phase II trial safety, efficacy (response rate) Progression free Survival, Overall 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	Calboplatin + pemetrexed Maintenance pemetrexed 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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	non squamous cell non-small cell lung carcinoma, advanced NSCLC, PS 0-1, good internal organs, Case of whom living for three months or more from administering start date is expected, Case who obtained agreement
Key exclusion criteria	1, squamou cell lung cancer 2, Interstitial change in chest X-ray or chest CT, 3, case of uncontrolled fluid 4, not medication of Vitanmin B12 and folic acid 5, Case who has serious renal dysfunction 6, Case of brain metastasis that has symptom 7, Case who has double cancer of briskness 8, case of uncontroled hypertension and diabetic 9, Case diagnosed as cirrhosis 10, Case who has cardiac illness etc
Target sample size	50

Research contact person
Name of lead principal investigator	Ichiro Kawase
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Thoracic Malignancy
Address	3-7-1 Habikino Habikino city Osaka Prefectural
TEL	072-957-2121
Email	moto19781205@yahoo.co.jp

Public contact
Name of contact person	Motohiro Tamiya
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Thoracic Malignancy
Address	3-7-1 Habikino Habikino city Osaka Prefectural
TEL	0729572121
Homepage URL
Email	moto19781205@yahoo.co.jp

Sponsor
Institute	1:Osaka Prefectural Medical Center for Respiratory and Allergic Diseases 2:Kinki-Chuo chest medical center
Institute
Department

Funding Source
Organization	1: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases 2: Kinki-Chuo chest medical center
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	1:大阪府立呼吸器・アレルギー医療センター 2:近畿中央胸部疾患センター

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 12 Month 01 Day
Anticipated trial start date	2010 Year 12 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 30 Day
Last modified on	2016 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005727