UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Acronym	A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Scientific Title	A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Scientific Title:Acronym	A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy and safety of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	One year survival
Key secondary outcomes	Evaluation of safety, Objective response rate, Progression Free 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	Four cycles of Pemetrexed + Carboplatin followed by maintenance Pemetrexed until disease progression
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent) 2) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST 3) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last dosage of adjuvant chemotherapy 4) Patients aged 20 years or older 5) Karnofsky performance status 70-100 6) Adequate organ function, evaluated within 14 days before enrollment as; WBC >= 4,000/mm3 Neu >= 2,000/mm3 Plt >= 100,000/mm3 Hb >= 9.5 g/dL AST/ALT <= x 3 upper limit of normal range T. Bil <= 1.5 g/dL Ccr >= 60mL/min or sCr <= 1.2mg/dL SpO2 >= 93% as room air 7) Excepted to live over 3 months after administration day 8) Written informed consent from the patients
Key exclusion criteria	Patients with at least one of the following conditions are ineligible 1) squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Pleural effusion, pericardial effusion and ascites to need treatment 4) Patients unable to take or unsupplied with folic acid and vitamin B12 5) Severe renal function disorder 6) SVC syndrome 7) Brain metastases with neurological symptoms 8) Active double cancer 9) Uncontrollable diabetes mellitus and hypertenson 10) Liver cirrhosis by image findings or laboratory examinations 11) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.) 12) Pregnancy, breast feeding and suspected pregnancy 13) History of grave drug allergic reaction 14) Acute inflammatory disease 15) An agreement is not obtained for support therapy such as transfusion etc 16) Having the bleeding tendency which is clinically apparent 17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Zip code
Address	2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL	06-6879-3833
Email

Public contact
Name of contact person	1st name Middle name Last name Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Zip code
Address	2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL	06-6879-3833
Homepage URL
Email	tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Dept. of Respiratory Medicine, Osaka University Hospital
Institute
Department

Funding Source
Organization	Dept. of Respiratory Medicine, Osaka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	OULCSG
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 15 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	2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2012 Year 11 Month 30 Day
Date of closure to data entry	2012 Year 11 Month 30 Day
Date trial data considered complete	2012 Year 11 Month 30 Day
Date analysis concluded	2012 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 14 Day
Last modified on	2012 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004549

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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