UMIN-CTR Clinical Trial

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

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