UMIN-CTR Clinical Trial

Recruitment status	Open public recruiting
Unique ID issued by UMIN	UMIN000021029
Receipt No.	R000023701
Official scientific title of the study	A randomized phase III trial of comparing two dose-fractionations stereotactic body radiotherapy (SBRT) for medically inoperable stage IA non-small cell lung cancer or small lung lesions clinically diagnosed as primary lung cancer (JCOG1408, J-SBRT trial)
Date of disclosure of the study information	2016/02/15
Last modified on	2017/11/21 (Ver. 7)

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Basic information

Official scientific title of the study

A randomized phase III trial of comparing two dose-fractionations stereotactic body radiotherapy (SBRT) for medically inoperable stage IA non-small cell lung cancer or small lung lesions clinically diagnosed as primary lung cancer (JCOG1408, J-SBRT trial)

Title of the study (Brief title)

Region

Japan

Condition

medically inoperable stage IA non-small cell lung cancer or small lung lesion (tumor diameter within 3cm) clinically diagnosed as primary lung cancer

Classification by specialty

Pneumology

Chest surgery

Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives
Narrative objectives1	To confirm the superiority of 55 Gy in 4 fractions of SBRT in terms of overall survival over 42 Gy in 4 fractions of SBRT for medically inoperable stage IA non-small cell lung cancer or small lung lesions clinically diagnosed as primary lung cancer patients in a Phase III design.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	progression-free survival, local progression-free survival, patterns of failure, local control period, early and late adverse events, serious adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A: stereotactic body radiotherapy 42 Gy/4 fractions

Interventions/Control_2

B: stereotactic body radiotherapy 55 Gy/4 fractions

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

years-old

Age-upper limit

years-old

Gender

Male and Female

Key inclusion criteria

1. Fulfilling the following conditions i) or ii) plus iii), and diagnosed with non-small cell lung cancer (NSCLC).
i) Histologically or cytologically confirmed NSCLC.
ii) Fulfilling both of the following conditions and clinically diagnosed as NSCLC.
a) increase in tumor size of 1 mm or more, or consolidation/tumor ratio turning >50% from <=50% on CT scans performed 28 days or more apart.
b) positive accumulation on FDG-PET.
iii) Small cell lung cancer is excluded.
2.Clinical T1N0M0 (c-stage IA) or small lung lesions (tumor diameter within 3 cm) clinically diagnosed as primary lung cancer with chest X-ray, enhanced chest and upper abdominal CT, enhanced cranial MRI, and FDG-PETwithin 56 days.
3. No lesions suspected of malignant tumor excluding non-invasive cancers (tumor diameter within 2cm and C/T ratio within 0.25) on imaging in the thorax other than primary lesion.
4. Aged 20-90 years old.
5. ECOG performance status of 0-2.
6. No previous thoracic radiotherapy. Previous radiations to contralateral breast and chest wall after surgery of breast cancers are allowed if they fulfill either of the following conditions. a) No overlap of radiation fields
b) The total skin maximum dose (D2%) <= 70 Gy
7. Diagnosed as inoperable by respiratory surgeons or refusing surgery.
8. Fulfilling the dose constraints in 55 Gy in 4 fractions on radiation treatment planning.
9. Sufficient organ functions; fulfilling all of the following conditions within 28 days;
i) White blood cell >=2,000/mm3
ii) Hemoglobin >= 8.0 g/dL
iii) Platelet >= 3.0*104 / mm3
iv) Total bilirubin <=2.0 mg/dL
v) Serum creatinine <=2.0 mg/dL
vi) FEV1.0 >=700 mL
vii) SpO2 (room air) >=90%
10. Written informed consent.

Key exclusion criteria

1. Synchronous or metachronous (within 5 years) malignancies.
2. Active infection requiring systemic therapy.
3. Body temperature of 38 or more degrees Celsius.
4. Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding.
5. Severe mental disease.
6. Receiving continuous systemic steroid or immune-suppressive medication.
7. Idiopathic pulmonary fibrosis on CT.
8. Severe cough requiring narcortic drugs.

Target sample size

750

Research contact person
Name of lead principal investigator	Yasushi Nagata
Organization	Hiroshima University Hospital
Division name	Department of Radiation Oncology
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan, 734-8551
TEL	082-257-1545
Email	nagat@hiroshima-u.ac.jp

Public contact
Name of contact person	Tomoki Kimura
Organization	JCOG1408 Coordinating Office
Division name	Department of Radiation Oncology, Hiroshima University Hospital
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan, 734-8551
TEL	082-257-1545
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

北海道大学病院（北海道）
札幌医科大学（北海道）
国立病院機構北海道がんセンター（北海道）
東北大学病院（宮城県）
仙台厚生病院（宮城県）
山形県立中央病院（山形県）
筑波大学医学医療系（茨城県）
栃木県立がんセンター（栃木県）
群馬大学医学部附属病院（群馬県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
千葉大学医学部（千葉県）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
東京女子医科大学（東京都）
慶應義塾大学病院（東京都）
昭和大学病院（東京都）
がん研究会有明病院（東京都）
東京大学医学部（東京都）
国立国際医療研究センター病院（東京都）
日本医科大学付属病院（東京都）
帝京大学医学部（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
横浜市立市民病院（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
山梨大学医学部（山梨県）
信州大学医学部（長野県）
岐阜市民病院（岐阜県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
京都大学医学部附属病院（京都府）
京都府立医科大学（京都府）
大阪大学医学部（大阪府）
近畿大学医学部（大阪府）
大阪国際がんセンター（大阪府）
大阪市立大学医学部附属病院（大阪府）
大阪府立病院機構大阪はびきの医療センター（大阪府）
大阪府立病院機構大阪急性期・総合医療センター（大阪府）
大阪市立総合医療センター（大阪府）
関西医科大学附属病院（大阪府）
兵庫県立がんセンター（兵庫県）
先端医療センター（兵庫県）
和歌山県立医科大学（和歌山県）
倉敷中央病院（岡山県）
岡山大学病院（岡山県）
広島大学病院（広島県）
国立病院機構山口宇部医療センター（山口県）
国立病院機構四国がんセンター（愛媛県）
九州大学病院（福岡県）
国立病院機構九州がんセンター（福岡県）
久留米大学医学部（福岡県）
長崎大学病院（長崎県）
琉球大学医学部附属病院（沖縄県）

Other administrative information

Date of disclosure of the study information

2016

Year

Month

Day

Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2015

Year

Month

Day

Anticipated trial start date

2016

Year

Month

Day

Last follow-up date

2027

Year

Month

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is conducted as intergroup study of Radiation Therapy Study Group and Lung Cancer Study Group.

Management information

Registered date

2016

Year

Month

Day

Last modified on

2017

Year

Month

Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023701