UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2010 Year 12 Month 22 Day
Date of IRB	2010 Year 12 Month 22 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
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	2022 Year 01 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005754