UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001328 |
|---|---|
| Receipt number | R000001592 |
| Scientific Title | Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer |
| Date of disclosure of the study information | 2008/08/23 |
| Last modified on | 2015/07/22 16:38:42 |
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Basic information
Public title
Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer
Acronym
Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer
Scientific Title
Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer
Scientific Title:Acronym
Biweekly Paclitaxel+Carboplatin for elderly patients with untreated nonresectable non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of biweekly Paclitaxel + Carboplatin for the elderly patients older than 70years old with nonressectable non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
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
Paclitaxel and carboplatin are given on day1 and day15 every 28days.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who were histologically or cytologically confirmed non-small cell lung cancer.
2)Patients who have measurable lesion.
3)No prior chemotherapy.
4)Stage IIIB or IV.
5)ECOG PS 0-2
6)Older than 70years old.
7)Patients who have adequate organ function.
WBC>=4000/mm3
neutrophil count>=2000/mm3
Platelet count>=100,000/mm3
Hemoglobin>=9.0g/dl
GOT,GPT within twice the upper limit of normal of institution
Serum creatinine <=1.5mg/dl
Normal ECG or UCG
8)Patients who have no severe complication.
9)Patients who have estimated life expectancy longer than 1 month.
10)Written informed consent.
Key exclusion criteria
1)Patients with severe heart disease.
2)Patients with recent history of myocardial infarction.
3)Patients with liver cirrhosis.
4)Patients with pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray.
5)Patients with severe diabetis mellitus.
6)Patients with ileus.
7)Patients with infection.
8)Patients with severe complications.
9)Patients with peripheral neuropathy.
10)Patients with severe mental disorder.
11)Patients with severe drug allergy.
12)Patients judged unfit to be enrolled in the study by the investigator .
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitoshi Ishizaka |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
Address
35 Shinanomachi-Shinjuku
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
hiroyukiyasuda@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine Division of Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine Division of Pulmonary Medicine
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
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
| 2008 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2006 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 20 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001592
