UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000072 |
|---|---|
| Receipt number | R000000119 |
| Scientific Title | A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer |
| Date of disclosure of the study information | 2005/08/22 |
| Last modified on | 2015/08/31 15:30:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer
Acronym
A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer
Scientific Title
A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer
Scientific Title:Acronym
A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer
Region
| Japan |
Condition
Condition
previously untreated elderly non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the toxicities and maximum tolerated dose (MTD) of gemcitabine with carboplatin, and to determine the recommended dose (RD) for previously untreated elderly non-small cell lung cancer (NSCLC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to establish MTD and to determine the RD
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
The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 1, and gemcitabine with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 and 8, every 3 weeks.
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
Patients with histologic or cytologic confirmation of locally advanced or metastatic NSCLC who received either no prior chemotherapy were eligible.
The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 70; (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; (4) adequate organ function
Key exclusion criteria
The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayasu Kurata |
Organization
Hyogo Medical Center for Adults
Division name
Department of Medical Oncology
Zip code
Address
13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558
TEL
078-929-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan 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
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
| 2005 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=22306126
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
| 2005 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | 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
| 2005 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000119
