UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005263 |
|---|---|
| Receipt number | R000006259 |
| Scientific Title | A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2011/03/17 |
| Last modified on | 2011/03/17 02:33:02 |
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Basic information
Public title
A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer
Acronym
A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer
Scientific Title
A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer
Scientific Title:Acronym
A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced 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 determine the maximum tolerated dose (MTD), and to evaluate pharmacokinetics (PK) and quality of life (QOL) of bi-weekly carboplatin (CBDCA) / paclitaxel (PTX) chemotherapy in elderly patients with non-small cell lung cancer (NSCLC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum Tolerated Dose of CBDCA+PTX bi-weekly therapy
Key secondary outcomes
Anti tumor efficacy, Quality of life
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
Eligibility criteria were histologically or cytologically confirmed NSCLC, no prior treatment, ECOG performance status (PS) 0-2 and age >70 years. PTX (90 or 100 mg/m2) were administered in combination with a fixed dose of CBDCA (area under the concentration-time curve; AUC of 3) on day 1 and 15 (every two 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
1)Histology/cytology-proven non-small cell lung cancer, age of 70 years or over
2)No prior chemotherapy or prior 1-regimen of EGFR TKI
3)ECOG performance status of 0-2
4)Adequate reserves for marrow, renal, hepatic, and pulmonary functions
5)Acquisition of written informed consent
Key exclusion criteria
1)Previous 2-regimen chemotherapy or 1-regimen of EGFR-TKI
2)Concurrent chemoradiotherapy
3)Serious infections
4)Ssymptomatic brain metastasis
5)Massive pericardial, pleural effusion, or ascites
6)Serious clinical probrems
7)Previous drug allergy or alchol allergy
8)Hoped to be pregnant/ nursing
9)Those judged to be not suitable by the attending physician
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Tsubata |
Organization
Shimane University Faculty of Medicine
Division name
Division of Clinical Oncology and Respiratory Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Division of Clinical Oncology and Respiratory Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine, Division of Clinical Oncology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine, Division of Clinical Oncology and Respiratory Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 03 | Month | 17 | 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 | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
| 2011 | Year | 03 | Month | 17 | Day |
Last modified on
| 2011 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006259
