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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019279
Receipt No. R000022294
Scientific Title Phase II trial of individualized lung tumor stereotactic ablative radiotherapy (iSABR)
Date of disclosure of the study information 2015/10/13
Last modified on 2018/05/08

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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
Middle name
Last name Shirato Hiroki
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL +81-11-706-5977
Email shirato@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shirato Hiroki
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL +81-11-706-5977
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2018 Year 05 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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