UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007587 |
|---|---|
| Receipt number | 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 05:44:26 |
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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
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
hitaniguchi-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008959
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