UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003586 |
|---|---|
| Receipt number | R000004347 |
| Scientific Title | A Phase II Study of Adjuvant Carboplatin and Weekly Paclitaxel in Patients with Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2015/11/10 12:54:33 |
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Basic information
Public title
A Phase II Study of Adjuvant Carboplatin and Weekly Paclitaxel in Patients with Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer
Acronym
A Phase II Study of Adjuvant Carboplatin and Weekly Paclitaxel in Patients with Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer
Scientific Title
A Phase II Study of Adjuvant Carboplatin and Weekly Paclitaxel in Patients with Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer
Scientific Title:Acronym
A Phase II Study of Adjuvant Carboplatin and Weekly Paclitaxel in Patients with Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of adjuvant carboplatin and weekly paclitaxel in patients with complately resected stage II-IIIA non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Incidence of an adverse event
Disease-free 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
carboplatin AUC5, day1 + paclitaxel 70mg/m2, day1,8,15
q4w, 4 courses
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) completely resected
2) histologically confirmed non-small-cell lung cancer
3) pathological stage IIA,IIB,IIIA
4) age 20-80 years old
5) performance status of 0-1
6) adequate organ function
.WBC >= 4,000 /mm3 and <=12,000 /mm3
.Platelet count >= 100,000/mm3
.Hemoglobin >= 9g/dL
.AST/ALT within 2.5 times the upper limit of normal (ULN) of institution
.Total serum bilirubin <= 1.5 mg/dL
.Serum creatinine <= 1.5 mg/dL
.Creatinine crearance >=50 ml/min/body
7) written informed consent
Key exclusion criteria
1) active interstitial pneumonitis determined by chest CT
2) active infection or gastric ulcer
3) drug allergy against polyoxethylated castor oil
4) active concomitant malignancy
5) severe complications
(i.e. heart diseases required treatment, myocardial infarction within 6 months, liver cirrhosis)
6) pregnant or lactating women
7) severe drug allergy
8) other conditions not suitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Rino |
Organization
Yokohama City University Hospital
Division name
Department of Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, kanagawa
TEL
045-787-2800
rino@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Arai |
Organization
Yokohama City University, Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, kanagawa
TEL
045-787-2800
Homepage URL
hiromasa@jg7.so-net.ne.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 10 | 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 | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
| 2010 | Year | 05 | Month | 10 | Day |
Last modified on
| 2015 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004347
