UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of topotecan and cisplatin for elderly small-cell lung cancer
Title of the study (Brief title)	Phase II study of topotecan and cisplatin for elderly small-cell lung cancer
Region	Japan

Condition
Condition	Elderly small-cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of the combination chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Adverse events, overall survival, 1-year survival rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination chemotherapy of topotecan and cisplatin
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	76 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically and/or cytologically proven SCLC No prior surgery, chemotherapy, or radiotherapy Age ≥76 ECOG performance status 0, 1 or 2 Measurable disease adequate bone marrow, lung, hepatic, and renal function Written informed consent
Key exclusion criteria	Active concomitant malignancy Active interstitial pneumonia Massive effusions Unstable angina, recent myocardial infarction Uncontrolled diabetes Symptomatic brain metastasis Severe active infection Other severe complications Inappropriate condition for this study judged by physicians.
Target sample size	55

Research contact person
Name of lead principal investigator	Mitsune Tanimoto
Organization	Okayama University Hospital
Division name	Hematology, Oncology, Respiratory Medicine
Address	2-5-1 Shikata-cho, Okayama 700-8558
TEL	086-235-7227
Email

Public contact
Name of contact person	Nagio Takigawa
Organization	Okayama Lung Cancer Study Group Coordinating Office
Division name	Okayama University Hospital, Respiratory Medicine
Address	2-5-1 Shikata-cho, Okayama 700-8558
TEL	086-235-7227
Homepage URL
Email	ntakigaw@md.okayama-u.ac.jp

Sponsor
Institute	Okayama Lung Cancer Study 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)

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 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 11 Month 05 Day
Anticipated trial start date	2004 Year 12 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete	2016 Year 06 Month 01 Day
Date analysis concluded	2016 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://link.springer.com/article/10.1007%2Fs00280-016-3135-2
Results	This regimen produced a favorable survival outcome (median: 22.2 months), despite moderate-to-severe toxicity profiles.
Other related information

Management information
Registered date	2005 Year 09 Month 08 Day
Last modified on	2016 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000197