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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002465
Receipt No. R000003018
Scientific Title A phase II trial of ifosphamide for patients with previously treated small cell lung cancer
Date of disclosure of the study information 2009/09/07
Last modified on 2017/07/25

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Basic information
Public title A phase II trial of ifosphamide for patients with previously treated small cell lung cancer
Acronym PII of IFM for SCLC
Scientific Title A phase II trial of ifosphamide for patients with previously treated small cell lung cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshinori Hasegawa
Organization Nagoya University Hospital
Division name respiratory medicine
Zip code
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
1st name
Middle name
Last name Ichidai Tanaka
Organization Nagoya University Graduate School of Medicine
Division name respiratory medicine
Zip code
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)

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
2009 Year 09 Month 07 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
2009 Year 06 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000003018

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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