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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000439
Receipt No. R000000533
Scientific Title Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Date of disclosure of the study information 2006/07/01
Last modified on 2010/11/04

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Basic information
Public title Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Acronym Phase1/2 study of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Scientific Title Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Scientific Title:Acronym Phase1/2 study of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Region
Japan

Condition
Condition Preaviously untreated advanced advanced squamous cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of gemcitabine and nedaplatin in patients with previously untreated squamous cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Recommended dose
Dose limmiting toxicity
Response Rate
Key secondary outcomes Overall survival
Time to progression
Toxicity

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 Combination chemotherapy with gemcitabine and nedaplation
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) Squamous cell lung cancer
2) Measurable lesions
3) Preaviously untreated advanced squamous cell lung cancer
4) PS(ECOG)0-1
5) Adequate organ fanctions
6) A life expectacy of at least 3 months
7) Written informed consent
Key exclusion criteria 1) Interstitial pneumonia or pulmonary fibrosis on chest X-P
2) peural or pericardial effusion requiring drainage
3) SVC syndrome
4) Symptomatic brain metastases
5) Active concominant malignancies
6) Uncontrolled diabetes mellitus or hypertension
7) Liver cirrhosis
8) Severe cardiovascular diseases
9) Pregnancy and lactation
10) Ccr<60ml/min
11) A history of serious drug allergy
12) Acute infection
13) Bleeding tendency
14) Unsuitable for entry to the study, decided by a medical oncologist
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Mio(Head),Katsuhiro Masago(Secretariat)
Organization Kyoto University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 54 Syogoin, Kawaramachi,Sakyo-Ku,Kyoto-City, Kyoto,Japan
TEL 075-751-3830
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiro Masago
Organization Kyoto unversity hospital
Division name Department of Respiratory Medicine
Zip code
Address 54 Syogoin, Kawaramachi,Sakyo-Ku,Kyoto-City, Kyoto,Japan
TEL 075-751-3830
Homepage URL
Email mio@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine of Kyoto 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
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 京都大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2006 Year 07 Month 01 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
Date of protocol fixation
2006 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2009 Year 07 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
2006 Year 06 Month 28 Day
Last modified on
2010 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000533

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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