UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007587
Receipt No. R000008959
Scientific Title A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.
Date of disclosure of the study information 2012/03/27
Last modified on 2020/10/07 (Ver. 5)

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Basic information
Public title A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.
Acronym A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.
Scientific Title A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.
Scientific Title:Acronym A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.
Region
Japan

Condition
Condition squamous cell Lung carcinoma
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of amrubicin and nedaplatin therapy for advanced or recurrent squamous cell Lung carcinoma
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 Progression-free survival, Overall survival

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 100mg/m^2 on day 1
Amrubicin 25mg/m^2 on day 1-3
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 confirmed squamous cell lung carcinoma.
2)Patients with clinical stageIIIb-
IV or postoperative recurrence.
3)no previous chemotherapy.
4)ECOG PS 0-1.
5)Patients with measurable leision (RECIST) .
6)Over 20 yeas old, under 75 years old.
7)Adequate main organ and bone marrow
function filled below criteria.
Leukocyte counts >= 4,000/mm3.
Neutrophil counts>= 2,000 /mm3.
Platelets >= 100,000 /mm3.
Hemoglobin >=9.0 g/dL.
AST, ALT< 2x upper normal limit.
T-Bil< 1.5 mg dL.
s-Cr < upper normal limit.
PaO2 >= 60 Torr or SpO2 >= 95%.
8)patients who has the following periods.
palliative radiotherapy(ex-thorax):2weeks.
Lobectomy of one or more lobe:4 weeks.
Operation without lobectomy.
chest drainage:2weeks.
radiotherapy for lung in perioperative period:6 months.
Patients have the prospective for
surviving more than 12 weeks.
Patients providing written informed
consent.
Key exclusion criteria 1)Symptomatic or apparent interstitial
pneumonia/lung fibrosis on X-ray image findings.
2)Patients wth uncontrollable fever.
3)Severe complications, such as cardiac.
failure, uncontrollable diabetic or hypertension.
4)uncontrollable pleural effusion, pericardial effusionor ascites.
5)Active concomitant malignancy.
6)Severe drug allergies or history of
drug hypersensitivity.
7)With active infection.
8)mental disorder.
9)Pregnant, lactating or women of
child-bearing potential.
10)The case that is judged to be
inadequacy for this study.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Kohno
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL 0958197273
Email hitaniguchi-ngs@umin.ac.jp

Public contact
Name of contact person
1st name Hirokazu
Middle name
Last name Taniguchi
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code 8528501
Address 1-7-1 Sakamoto Nagasaki
TEL 0958197273
Homepage URL
Email hitaniguchi-ngs@umin.ac.jp

Sponsor
Institute Nagasaki Thoracic Oncology Group
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 Nagasaki University Hospital
Address 1-7-1 Sakamoto Nagasaki
Tel 0958197273
Email hitaniguchi-ngs@umin.ac.jp

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 03 Month 27 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.13134
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.13134
Number of participants that the trial has enrolled 21
Results 
Partial response was observed in seven of 21 cases (ORR, 33.3%; 95% confidence interval [CI], 14.5-52.2). Disease control rate, which includes stable disease, was 71.4%. Median OS and PFS was 14.6 and 4.1 months, respectively.
Results date posted
2020 Year 10 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
A total of 21 patients from six institutions were enrolled. The study population mainly comprised men with a current or previous history of smoking. The median age was 66 years, ranging from 55 to 75 years.
Participant flow 
The patients who consented the study and met the eligibility criteria for this study were as
Adverse events 
This regimen did not cause any treatment-related deaths. 
Grade 3/4 neutropenia developed in 8 of 21 cases (38.1%); however, febrile neutropenia developed in only 9.5% of the cases. Grade 3/4 gastrointestinal or neuromuscular toxicities were not observed.
Outcome measures 
Partial response was observed in seven of 21 cases (ORR, 33.3%; 95% confidence interval [CI], 14.5-52.2). Disease control rate, which includes stable disease, was 71.4%. Median OS and PFS was 14.6 and 4.1 months, respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
2012 Year 01 Month 30 Day
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2018 Year 05 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
2012 Year 03 Month 27 Day
Last modified on
2020 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008959