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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007054
Receipt No. R000008313
Scientific Title Phase II study of nedaplatin for advanced or relapsed squamous cell lung cancer in chemo-naive elderly patients
Date of disclosure of the study information 2012/01/12
Last modified on 2015/06/22

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Basic information
Public title Phase II study of nedaplatin for advanced or relapsed squamous cell lung cancer in chemo-naive elderly patients
Acronym Phase II study of nedaplatin for advanced squamous cell lung cancer in elderly patients
Scientific Title Phase II study of nedaplatin for advanced or relapsed squamous cell lung cancer in chemo-naive elderly patients
Scientific Title:Acronym Phase II study of nedaplatin for advanced squamous cell lung cancer in elderly patients
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of nedaplatin for chemo-naive squamous cell lung cancer in elderly patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes Overall survival, Progression free survival, Adverse events

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 Nedaplatin 80-100mg/m2 day 1, q4w until disease progression or intolerable toxicity.
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven squamous cell lung cancer.
2) Chemo-naive clinical stage IIIB/IV or relapsed patients.
3) Age of 75 years or older.
4) Performance status (PS) of 0-1 in ECOG criteria.
5) Adequate organ functions.
6) With measurable lesion.
7) Life expectancy more than 3 months.
8) Written informed consent.
Key exclusion criteria 1) Patients with brain metastasis in need of steroid or anticonvulsant.
2) Less than 4 weeks after curative radiotherapy to primary lesion or less than 2 weeks after palliative radiotherapy.
3) History of active double cancer.
4) Patients with superior vena cava syndrome.
5) Uncontrollable pleural effusion, pericardial effusion or ascites.
6) History of uncontrollable hypertension, diabetes mellitus, active angina pectoris, active gastrointestinal hemorrhage, recent cardiac incompetence, recent myocardial infarction and active viral infection (except viral hepatitis).
7) Interstitial shadow of UIP (usual interstitial pneumonia) pattern on chest CT.
8) History of severe drug allergy.
9) History of severe psychiatric disease.
10) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-chou, Suntou-gun, Shizuoka, Japan
TEL 055-989-5222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuhiko Taira
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-chou, Suntou-gun, Shizuoka, Japan
TEL 055-989-5222
Homepage URL
Email

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization None
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
2012 Year 01 Month 12 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
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2012 Year 01 Month 11 Day
Last modified on
2015 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008313

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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