UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of ifosphamide for patients with previously treated small cell lung cancer
Title of the study (Brief title)	PII of IFM for SCLC
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of ifosphamide for previously treated small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival median survival time Safety(incidence of adverse event)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ifosphamide
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Histologically or cytologically proven small-cell lung cancer 2 Age between 20 and 75 years 3 Have measurable lesions as defined by RECIST 4 Confirmation of progressive disease, refractory disease, or relapse after first chemotherapy(both limited and extensive stage) 5 Prior one more chemotherapeutic regimen 6 At least 4 weeks must have elapsed since radiotherapy 7 Adequate organ functions Neutrophil count>=1500/mm3 Platelet count>=100,000/mm3 Hemoglobin>=9.0g/dl Serum creatinine<=1.5mg/dl Serum bilirubin<=1.5mg/dl AST/ALT<=100mg/dl 8 ECG: no abnormality needed therapy 9 Performance status(ECOG)0-2 10 Life expectancy more than 12 weeks 11 Written informed consent
Key exclusion criteria	1 severe pleural, pericardial effusion, ascites or supra vena cava syndrome 2 sever complication(severe cardiac disease, heart failure, myocardial infarction and angina pectoris within the last 6 months, cerebrovascular disease within the last 6 months, poorly controlled hypertension, active infection)and another active cancer 3 symptomatic brain metastases 4 pregnancy, intent to became pregnant,or breast-feeding 5 active psychological disease 6 non eligible cases judged by investigators
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshinori Hasegawa
Organization	Nagoya University Hospital
Division name	respiratory medicine
Address	65 turumai-tyo showa-ku nagoya-sia-ku nagoya-si
TEL	052-481-5111
Email	yhasega@med.nagoya-u.ac.jp

Public contact
Name of contact person	Ichidai Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	respiratory medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2167
Homepage URL
Email	ichidai1104@hotmail.co.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya first red cross hospital
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

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 06 Month 25 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2013 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 09 Month 07 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003018