UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of individualized lung tumor stereotactic ablative radiotherapy (iSABR)
Acronym	Phase II trial of individualized lung tumor stereotactic ablative radiotherapy (iSABR)
Scientific Title	Phase II trial of individualized lung tumor stereotactic ablative radiotherapy (iSABR)
Scientific Title:Acronym	Phase II trial of individualized lung tumor stereotactic ablative radiotherapy (iSABR)
Region	Japan

Condition
Condition	Primary or metastatic lung cancer
Classification by specialty	Medicine in general Radiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The primary objective is to evaluate the local control of individually optimized lung tumor SABR. Secondary objectives include evaluation of toxicity and evaluation of the feasibility of anatomically optimized AVB-coached breath-hold technique assisted by fast delivery using gated RapidArc with FFF in a subset of patients. Additional secondary objectives include determining progression free, metastasis free, and overall survival in patients treated with individually optimized lung tumor SABR.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Local tumor control of individually optimized lung tumor SABR at 12 months after treatment. Local failure will be defined as tumor biopsy and/or radiographic progression on CT and/or PET/CT.
Key secondary outcomes	Toxicity of individually optimized lung tumor SABR Feasibility of anatomically optimized AVB-coached breath-hold technique assisted by fast delivery using gated RapidArc with FFF in a subset of patients. Feasibility will be assessed based on: (1) The proportion of patients able to reproduce an anatomically-optimized breath-hold with AVB-coaching during treatment. (2) The reduction in treatment delivery time compared to gated free-breathing treatment. Metastasis free and overall survival in patients treated with SABR.

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	Device,equipment
Interventions/Control_1	Stereotactic body 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases. 2) Up to 4 lesions may be included. For a single lesion the sum of three orthogonal diameters can be no more than 20 cm. For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm. 3) Both peripheral and central tumors are accepted for this trial. 4) Age > 18 years old 5) Both men and women and members of all races and ethnic groups are eligible for this trial. Note: Patients may be enrolled more than once (eg, for a new tumor)
Key exclusion criteria	1) Evidence of uncontrolled extrathoracic metastases 2) Contraindication to receiving radiotherapy 3) Age < 18 years old. Children are excluded because lung malignancies rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room. 4) Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5) Prior radiation therapy is allowed but there should not be overlap with the prior high dose regions unless approved by the protocol directors.
Target sample size	260

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Shirato
Organization	Hokkaido University Graduate School
Division name	Graduate school of medicine
Zip code	0608646
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido
TEL	+81-11-706-8517
Email	shirato@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Shirato
Organization	Hokkaido University Graduate School
Division name	Graduate School of Medicine
Zip code	0608646
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido
TEL	+81-11-706-8517
Homepage URL
Email	shirato@med.hokudai.ac.jp

Sponsor
Institute	Stanford Cancer Center 875 Blake Wilbur Drive Stanford, CA 94305
Institute
Department

Funding Source
Organization	Global Institution for Collaborative Research and Education GI-CoRE
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Hospital Division of Clinical Research Administration
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido
Tel	+81-11-706-7636
Email	crjimu@huhp.hokudai.ac.jp

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 10 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	217
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 25 Day
Date of IRB	2015 Year 09 Month 24 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry	2022 Year 02 Month 09 Day
Date trial data considered complete	2022 Year 02 Month 09 Day
Date analysis concluded	2022 Year 02 Month 09 Day

Other
Other related information

Management information
Registered date	2015 Year 10 Month 08 Day
Last modified on	2022 Year 02 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022294