UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study to evaluate effectiveness of prophylactic cranial irradiation on patients with limited-stage small cell lung cancer.
Title of the study (Brief title)	Observational study of PCI on LS-SCLC
Region	Japan

Condition
Condition	Limited-stage small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the efficacy of prophylactic cranial irradiation in patients with limited stage small cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of brain metastasis
Key secondary outcomes	Overall survival time, Quality of life (QCQ-C30/BN20), cognitive ability (MMSE)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Histologically or cytologically confirmed small cell lung cancer in limited-stage (IA to IIIB) 2. Responded to first treatment to complete response or good partial response (short axis of all mediastinal lymphnodes <15mm, no persisting primary lesion) 3. Confirmed absence of brain metastasis with enhanced cranial MRI within 2 months after the finish of initial treatment
Key exclusion criteria	1. Patients with brain metastasis 2. Patients judged as inappropriate for this study by investigators
Target sample size	98

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu Univ. School of Medicine
Division name	Department of Internal Medicine, second division
Address	Handayama 1-20-1, Hamamatsu, Shizuoka, Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	koji Nishimoto
Organization	Hamamatsu Univ. School of Medicine
Division name	Department of Internal Medicine, second division
Address	Handayama 1-20-1, Hamamatsu, Shizuoka, Japan
TEL	053-435-2263
Homepage URL
Email	knishi@hama-med.ac.jp

Sponsor
Institute	Hamamatsu Shizuoka Respiratory Group
Institute
Department

Funding Source
Organization	Seirei Mikatahara General Hospital
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	2015 Year 07 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cranial MRI: Every 3 months for first 2 years and every 6 months after that. QOL (QCQ-C30/BN20), cognitive ability: Every 6 months for first 1 year and every 12 months after that.

Management information
Registered date	2015 Year 07 Month 09 Day
Last modified on	2018 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021040