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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027231
Receipt No. R000031201
Scientific Title Stereotactic body radiotherapy for stage I non-small-cell lung cancer using higher doses for lager tumors: employing escalated doses
Date of disclosure of the study information 2017/05/03
Last modified on 2017/11/15

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Basic information
Public title Stereotactic body radiotherapy for stage I non-small-cell lung cancer using higher doses for lager tumors: employing escalated doses
Acronym Stereotactic body radiotherapy for stage I non-small-cell lung cancer using higher doses for lager tumors: employing escalated doses
Scientific Title Stereotactic body radiotherapy for stage I non-small-cell lung cancer using higher doses for lager tumors: employing escalated doses
Scientific Title:Acronym Stereotactic body radiotherapy for stage I non-small-cell lung cancer using higher doses for lager tumors: employing escalated doses
Region
Japan

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

Objectives
Narrative objectives1 To investigate efficacy and safety of stereotactic radiotherapy employing escalated doses.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival rate
Key secondary outcomes progression-free survival rate, local control rate, adverse event

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
Other
Interventions/Control_1 Perform stereotactic radiotherapy for primary lung cancer.
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)Histologically confirmed stage I NSCLC diagnosed according to the 7th TNM classification of lung cancer by the Union for International Cancer Control by chest and upper abdomen CT, brain MRI, and bone scintigraphy or FDG-PET.
(2)Greatest tumor diameter <= 5 cm.
(3)World Health Organization performance status (PS) <= 2 or PS 3 when its cause was not a pulmonary disease.
(4)No prior therapy and no concurrent malignancy.
(5)Arterial oxygen pressure >= 60 mmHg, and forced expiratory volume in 1 second >= 700 ml.
Key exclusion criteria (1)No serious diabetes, collagen disease, cardiac disease, pulmonary disease, kidney disease and psychological disorder.
(2)Single lung.
(3)Receiving home oxygen therapy.
(4)Pregnant or lactating woman, likelihood of pregnancy.
(5)Active infectious disease.
(6)Implanted pacemaker or implantable cardioverter defibrillator.
(7)No history of thoracic radiation therapy.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Miyakawa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Radiology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL 052-853-8274
Email amiyakawa21@triton.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akifumi Miyakawa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Radiology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL 052-853-8274
Homepage URL
Email amiyakawa21@triton.ocn.ne.jp

Sponsor
Institute Department of Radiology, Nagoya City University Graduate School of Medical Sciences
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)

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
2017 Year 05 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://ro-journal.biomedcentral.com/articles/10.1186/s13014-017-0888-7
Number of participants that the trial has enrolled
Results
Background
Efficacy of stereotactic body radiotherapy (SBRT) in stage I non-small-cell lung cancer (NSCLC) has almost been established. In Japan, the protocol of 48 Gy in 4 fractions over 4 days has been most often employed, but higher doses may be necessary to control large tumors. Previously, we conducted a clinical study using SBRT for stage I NSCLC employing different doses depending on tumor diameter, which was closed in 2008. Thereafter, a new study employing higher doses has been conducted, which is reported here. The purpose of this study was to review the safety and effectiveness of the higher doses.
Methods
We escalated the total dose for the improvement of local control for large tumors. In this study, 71 patients underwent SBRT between December 2008 and April 2014. Isocenter doses of 48, 50, and 52 Gy were administered for tumors with a longest diameter of < 1.5 cm, 1.5-3 cm, and > 3 cm, respectively. It was recommended to cover 95% of the PTV with at least 90% of the isocenter dose, and in all but one cases, 95% of the PTV received at least 80% of the prescribed dose. Treatments were delivered in 4 fractions, giving 2 fractions per week. SBRT was performed with 6-MV photons using 4 non-coplanar and 3 coplanar beams.
Results
The median follow-up period was 44 months for all patients and 61 months for living patients. Overall survival (OS) was 65%, progression-free survival (PFS) was 55%, and cumulative incidence of local recurrence (LR) was 15% at 5 years. The 5-year OS was 69% for 57 stage IA patients and 53% for 14 stage IB patients (p = 0.44). The 5-year PFS was 55% and 54%, respectively (p = 0.98). The 5-year cumulative incidence of LR was 11% and 31%, respectively (p = 0.09). The cumulative incidence of Grade  2 radiation pneumonitis was > 25%.
Conclusions
Our newer SBRT study yielded reasonable local control and overall survival and acceptable toxicity, but escalating the total dose did not lead to improved outcomes.
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 Main results already published
Date of protocol fixation
2008 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 15 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 05 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 30 Day
Date analysis concluded
2017 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 03 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031201

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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