UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable nonsquamous non-small cell lung cancer
Acronym	Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable
Scientific Title	Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable nonsquamous non-small cell lung cancer
Scientific Title:Acronym	Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable
Region	Japan

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

Objectives
Narrative objectives1	We planned to do phase I/II studies of pemetrexed and cisplatin with concurrent chemoradiotherapy. Our objectives are to define the maximum-tolerated dose and dose-limiting toxicity in the phase 1 study, and to determine the response rate, toxicity, and survival rate at the recommended dose in the phase 2 study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase 1:Dose Limiting Toxicity, Maximum Tolerated Dose Phase 2:Response rate
Key secondary outcomes	Phase 1:Response rate Phase 2:Toxicity, Median survival time

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 Device,equipment
Interventions/Control_1	Pemetrexed, Cisplatin, Radiotherapy
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Pathologically confirmed non-squamous non-small cell lung cancer 2)Unresectable stage 3A or3B 3)No previous treatment 4)An age of 20-70 years 5)ECOG performance status (PS) of 0 or 1 6)A life expectancy of 3 months or longer 7)Adequate organ function 8)Written informed consent
Key exclusion criteria	1)Active systemic infection 2)Pregnancy or lactation 3)Ascitic fluid or pleural effusion 4)Pericardial fluid retention 5)Peripheral neuropathy
Target sample size	56

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshinobu Iwasaki
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pulmonary Medicine
Zip code
Address	465, Kawaramachi, Hirokoji Kamigyo-ku, Kyoto
TEL	075-251-5513
Email

Public contact
Name of contact person	1st name Middle name Last name Yoshinobu Iwasaki
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pulmonary Medicine
Zip code
Address	465, Kawaramachi, Hirokoji Kamigyo-ku, Kyoto
TEL	075-251-5513
Homepage URL	http://www.f.kpu-m.ac.jp/k/respir/
Email	yiwasaki@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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
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

Other administrative information
Date of disclosure of the study information	2010 Year 06 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	2010 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date	2010 Year 05 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 05 Month 18 Day
Last modified on	2015 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004244

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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