UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor
Title of the study (Brief title)	Dose escalation study in stereotactic body radiotherapy for the lung tumor
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and the efficacy of the dose escalation in stereotactic body radiotherapy for the lung tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of adverse effect
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Dose escalation in radiotherapy
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) Primary or metastatic lung cancer A. Primary lung cancer; Tumor size </=5cm, and clinical stage IA or IB B. Metastatic lung cancer; Tumor size </=5cm, two lung lesions or less, and no lesions other than lung 2) Those who are inoperable or who refuse surgery 3) Dose to adjacent organ is not estimated to exceed constraints in pretreatment chest CT 4) Patients' age must be>/=20 years old 5) ECOG performance status must be 0-2 6) Patients can lay on their back holding their arms over the heads, and keep that position at least 30 minutes
Key exclusion criteria	1) previous irradiation around the lesion 2) With active interstitial pneumonia or pulmonary fibrosis 3) With severe diabetic mellitus or collagen disease 4) Women during pregnancy or lactating , or who might be pregnant 5) With psychiatric illness which impede protocol treatment 6) Patients who are considered to be inappropriate for this study by physicians
Target sample size	35

Research contact person
Name of lead principal investigator	Yukinori Matsuo
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Radiation Oncology and Image-applied Therapy
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL	075-751-3762
Email	ymastuo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Takamasa Mitsuyoshi
Organization	Kyoto University Hospital
Division name	Department of Radiation Therapy
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL	075-751-3762
Homepage URL
Email	mitsu.t@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
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	2014 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 05 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 10 Day
Last modified on	2018 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017225