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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004833
Receipt No. R000005754
Scientific Title Phase 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 2011/01/06
Last modified on 2011/11/07

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

Condition
Condition Lung squamous cell carcinoma
Classification by specialty
Pneumology Chest surgery
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

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival
Overall Survival
Toxicity
Feasibility(Dose Intensity)

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) Histologically or cytologically proven squamous cell lung cancer.
2) Stage III/IV without indication for curative resection and post-operative recurrent disease.
3) Target lesion is measurable(RECISTver1.1).
4) Patients aged 20 or over.
5) ECOG performance status 0-1.
6) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
Leukocyte counts, 4,000/mm3 to 12,000/mm3.
Neutrophil counts, 2,000/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0g/dL or over
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
Arterial oxygen partial pressure 60 Torr or above.
Adequate heart function by ECG.
LVEF, 60% or over.
7) Patients without active interstitial pneumonia recognized by chest X-ray.
8) Excepted to live over 12 weeks after administration day.
9) Written informed consent from the patients.
Key exclusion criteria 1) Active infectious disease
2) Patients with fever above 38 degrees.
3) Patients with severe complications.
4) Active concominant malignancies.
5) Patients with symptomatic brain metastasis.
6) Pleural effusion, pericardial effusion and ascites to need treatment
7) Patients with a history of hypersensitivity to the gemcitabine or nedaplation.
8) History of pregnancy or lactation.
9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name FUNAI Kazuhito
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
Homepage URL
Email

Sponsor
Institute First Department of Surgery, Hamamatsu University School of Medicine
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 磐田市立総合病院(静岡県)、聖隷浜松病院(静岡県)、浜松医療センター(静岡県)、藤枝市立総合病院(静岡県)、富士宮市立病院(静岡県)、焼津市立総合病院(静岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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
2011 Year 01 Month 06 Day
Last modified on
2011 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005754

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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