UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000128
Receipt No. R000000191
Scientific Title A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
Date of disclosure of the study information 2005/09/07
Last modified on 2015/08/31

* 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 topotecan with carboplatin for relapsed small cell lung cancer
Acronym A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
Scientific Title A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
Scientific Title:Acronym A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer
Region
Japan

Condition
Condition relapsed 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 topotecan with carboplatin, and to determine the recommended dose (RD) for relapsed small cell lung cancer (SCLC).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

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 5, and topotecan with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 to 5, 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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with histologic or cytologic confirmation of SCLC who received one prior chemotherapy regimen were eligible.
The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 20, <75; (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 38

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization Hyogo Medical Center for Adults
Division name Department of Medical Oncology
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
2005 Year 09 Month 07 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=19325498
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
2002 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2002 Year 09 Month 01 Day
Last follow-up date
2005 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 05 Month 01 Day
Date trial data considered complete
2007 Year 06 Month 01 Day
Date analysis concluded
2007 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 07 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000191

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.