UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer
Acronym	Maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin
Scientific Title	A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer
Scientific Title:Acronym	Maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin
Region	Japan

Condition
Condition	advanced non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to compare the efficacy and safety of pemetrexed to those of docetaxel as maintenance therapy in patients without progressive disease after receiving treatment with pemetrexed plus carboplatin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	survival without grade 3/4 toxicity
Key secondary outcomes	response rate, overall survival, progression free survival, safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients were included in the run-in phase (four cycles of carboplatin plus pemetrexed).The end of the run-in phase, patients who did not have progressive disease were randomly allocated to pemetrexed.
Interventions/Control_2	Patients were included in the run-in phase (four cycles of carboplatin plus pemetrexed).The end of the run-in phase, patients who did not have progressive disease were randomly allocated to docetaxel.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	All participants must meet the following criterias 1: Histologically or pathologically proven NSCLC 2: Radiographically measurable lesion 3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4: Stage 3B/4 NSCLC 5: Age more than 20 years and less than 75 years 6: Neutrophil count: more than 1,500/uL Platelet count: more than 100,000/uL Hemoglobin: more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range Total bilirubin: less than 1.5mg/dL. PaO2: more than 60 torr Creatinine: less than 1.2mg/dL or a calculated creatinine clearance more than 45 mL/min 7: Life expectancy of more than 12 weeks 8: Written informed consent
Key exclusion criteria	Exclusion criterias are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Uncontrolled massive pleural effusion or cardiac effusion 4: Superior vena cava syndrome 5: Uncontrolled brain metastases 6: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 12 months 7: Severe infection 8: Pregnancy or lactation 9: Active concomitant malignancy 10: History of severe allergic reactions to drugs 11: Severe and unstable medical comorbidities 12: Judgment to attending physician
Target sample size	84

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kingo Chida
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code
Address	1-20-1 Handayama Hamamatsu Shizuoka 431-3192 Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Naoki inui
Organization	Hamamatsu University School of Medicine
Division name	Clinical Pharmacology and Therapeutics
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
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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	浜松医科大学附属病院（静岡県）

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 31 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	Completed
Date of protocol fixation	2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 08 Month 20 Day
Last modified on	2012 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004905

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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