UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002465 |
|---|---|
| Receipt number | 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 17:15:37 |
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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
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
ichidai1104@hotmail.co.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
