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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005263
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Shimane University Faculty of Medicine, Division of Clinical Oncology and Respiratory Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006259

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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