UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000112 |
|---|---|
| Receipt number | R000000164 |
| Scientific Title | Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer |
| Date of disclosure of the study information | 2005/09/04 |
| Last modified on | 2005/09/04 22:14:27 |
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Basic information
Public title
Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Acronym
Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Scientific Title
Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Scientific Title:Acronym
Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carboplatin and gemcitabine in elderly patients with advanced non-small cell lung cancer
Basic objectives2
Safety,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
day 1: CBDCA 4AUC GEM 1000mg/m2
day 8: GEM 1000mg/m2
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 histologically or cytologically confirmed NSCLC who were 70 years or older at diagnosis, had measurable disease on thoracic computed tomography (CT) scans, and had not previously received chemotherapy were eligible for enrollment in the study. An additional requirement was that the disease was inoperable as a result of substantial comorbidity, impairment of respiratory function, or anatomic contraindication. Patients who relapsed after complete tumor resection or in whom resection was incomplete were also eligible. Further entry criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as well as adequate bone marrow (leukocyte count, 4000 to 12,000/µL; hemoglobin concentration, >9.0 g/dL; platelet count, >100,000/µL), renal (serum creatinine concentration, <1.5 mg/dL), hepatic (serum aspartate aminotransferase and alanine aminotransferase , <1.5 times the upper limit of the normal range; serum total bilirubin, <1.5 mg/dL), and pulmonary (PaO2, >70 torr) function.
Key exclusion criteria
Individuals with active infection, severe heart disease, active concomitant malignancy, or pleural or pericardial effusion requiring drainage were excluded.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isamu Okamoto |
Organization
Kinki University School of Medicine
Division name
Department of Medical Oncology,
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama,
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ji-ichiro Sasaki |
Organization
Kumamoto University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
saji@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University School of 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
| 2005 | Year | 09 | Month | 04 | 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
Date of protocol fixation
| 2004 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 10 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2005 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000164
