UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation
Title of the study (Brief title)	Prospective study of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation
Region	Japan

Condition
Condition	primary lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the outcome of stereotactic body radiotherapy for small lung lesions clinically diagnosed as primary lung cancer without pathologic confirmation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	overall survival rate
Key secondary outcomes	progression-free survival rate, safety

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) Patients with lung tumor less than 3cm in diameter and less than three lesions. 2) Patients unable to confirm pathological diagnosis. 3) Positive on FDG-PET except patients with GGO. 4) Apparent growth of lung tumor on CT. 5) Aged 20 years or more, 0-2 of ECOG performance status. 6) Patients must be consulted by surgeon. 7) Patients must be consulted by internal physician. 8) Able to make planning of radiotherapy within the regulation dose. 9) No history of radiation for chest. 10) PaO2 60 torr or more at room air, FEV1.0 700 ml or more.
Key exclusion criteria	1) Apparent interstitial pneumonia on chest X-ray. 2) Patinets with active infectious disease. 3) Patients with active other cancers. 4) Pregnant patients. 5) Patients with psychiatric disorders and unable to participate the study. 6) Patients now treated by steroids. 7) Patients who need oxygen inhalation. 8) Fever up.
Target sample size	65

Research contact person
Name of lead principal investigator	Hiroki Shirato
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Radiology
Address	North 15 West 7, Kita-ku, Sapporo, Japan
TEL	011-706-5977
Email	shirato@med.hokudai.ac.jp

Public contact
Name of contact person	Tetsuya Inoue
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Radiology
Address	North 15 West 7, Kita-ku, Sapporo, Japan
TEL	011-706-5977
Homepage URL
Email	t-inoue@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Research group for low-risk and high-dose radiotherapy by highly advanced technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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	北海道大学病院、他11施設

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 21 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2017 Year 08 Month 14 Day
Date of closure to data entry	2017 Year 09 Month 07 Day
Date trial data considered complete	2017 Year 09 Month 07 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	With a median follow-up period of 55 months, the 3-year overall survival rate was 83% (95%CI:71-91%). Grade 3 and 4 chronic adverse event was experienced in 8 and 1 patients, respectively.
Other related information	We observe patients treated by stereotactic body radiotherapy, who were clinically diagnosed as primary lung cancer without pathologic confirmation.

Management information
Registered date	2009 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002989