UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Stereotactic body radiotherapy for stage I non-small-cell lung cancer using higher doses for lager tumors: employing escalated doses
Title of the study (Brief title)	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	Akifumi Miyakawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
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	Akifumi Miyakawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://ro-journal.biomedcentral.com/articles/10.1186/s13014-017-0888-7
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.
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/icdr_e/ctr_view.cgi?recptno=R000031201