UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study for dose escalation in limited small cell lung cancer
Title of the study (Brief title)	Phase I study for dose escalation in limited small cell lung cancer
Region	Japan

Condition
Condition	Limited small cell lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety of dose escalation in radiotherapy in limited small cell lung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Acute toxicity G3 or more
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	Maneuver
Interventions/Control_1	3DCRT:Radiotherapy Arm 1:48Gy1.5 Gyb.i.d./22d Arm 2:54Gy1/24d Arm 3:60Gy/4wks=26d Arm 4:66Gy32d
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 diagnosed as a limited NSCLC 2) Fresh case 3) ECOG PD 0-1 4) Wtitten informed consent
Key exclusion criteria	1) Uncontrollable DM 2) Collagen disease 3) Concurrent cancer with activity 4) Pregnant 5) Elonging treatment time
Target sample size	30

Research contact person
Name of lead principal investigator	Hideya Yamazaki
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Radiology
Address	465 Kajiicho Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566 Japan
TEL	075-251-5111
Email	yamahi@koto.kpu-m.ac.jp

Public contact
Name of contact person	office
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	IRB
Address	465 Kajiicho Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566 Japan
TEL	075-251-5111
Homepage URL
Email	rinri@koto.kpu-m.ac.jp

Sponsor
Institute	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
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	京都府立医科大学病院（京都府）

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 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

Management information
Registered date	2011 Year 07 Month 02 Day
Last modified on	2018 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006990