UMIN-CTR Clinical Trial

Basic information
Public title	Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Acronym	Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Scientific Title	Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Scientific Title:Acronym	Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of PEM monotherapy for elderly patients in advanced non-squamous non-small cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Safety, Response rate, Rate of treatment completion

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment with pemetrexed (500mg/m2)
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	1. Pathologically or cytologically diagnosed stage IIIB, stage IV or recurrence non-squamous non-small cell lung cancer 2. Without receiving cytotoxic agents chemotherapy 3. ECOG PS of 0-1 4. Life expectancy of more than 12 weekss 5. Adequate organ function Neutrophil cout of more than 1,500/mm3 Platelet cout of more than 100,000/mm3 Aspartate transaminase (AST), alanine transaminase(ALT): less than 100IU/L Total bilirubin: less than 1.5mg/dL Serum creatinine of less than 1.5mg/dL or creatinine clearance of less than 45mL/min
Key exclusion criteria	1. Superior vena cava syndrome 2. History of severe hypersensitivity to drugs 3. Uncontrolled pleural effusion, peritoneal effusion, and cardiac effusion 4. Severe infectious disease or severe uncontrolled complication 5. Interstitial lung disease or pulmonary fibrosis 6. Active malignancy of other organ
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Toshihiko Kaneda
Organization	Kurashiki Central Hospital
Division name	Department of respiratory medicine
Zip code
Address	1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL	086-422-0210
Email	tk15127@kchnet.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Toshihiko Kaneda
Organization	Kurashiki Central Hospital
Division name	Department of respiratory medicine
Zip code
Address	1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL	086-422-0210
Homepage URL
Email	tk15127@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	公益財団法人大原記念倉敷中央医療機構 倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 30 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028734