UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021029 |
|---|---|
| Receipt number | R000023701 |
| Scientific Title | 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 18:49:38 |
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Basic information
Public title
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)
Acronym
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)
Scientific Title
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)
Scientific Title:Acronym
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)
Region
| Japan |
Condition
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
NO
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
2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | 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
| 1st name | |
| Middle name | |
| Last name | Yasushi Nagata |
Organization
Hiroshima University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan, 734-8551
TEL
082-257-1545
nagat@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Kimura |
Organization
JCOG1408 Coordinating Office
Division name
Department of Radiation Oncology, Hiroshima University Hospital
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan, 734-8551
TEL
082-257-1545
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
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 | 02 | Month | 15 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
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 | 02 | Month | 15 | Day |
Last modified on
| 2017 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023701
