UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027231
Receipt number	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 10:43:48

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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

primary lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

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

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

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 or person

Institute

Department of Radiology, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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