UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019279 |
|---|---|
| Receipt number | 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 | 2022/02/14 16:02:12 |
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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 | 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
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
shirato@med.hokudai.ac.jp
Sponsor or person
Institute
Stanford Cancer Center
875 Blake Wilbur Drive
Stanford, CA 94305
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022294
