UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038935 |
|---|---|
| Receipt number | R000044400 |
| Scientific Title | A multicenter non-randomized confirmatory trial of stereotactic body radiation therapy for solitary lung tumor after complete resection of non-small cell lung cancer (JROSG17-4) |
| Date of disclosure of the study information | 2019/12/19 |
| Last modified on | 2023/01/31 18:30:16 |
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Basic information
Public title
A multicenter non-randomized confirmatory trial of stereotactic body radiation therapy for solitary lung tumor after complete resection of non-small cell lung cancer (JROSG17-4)
Acronym
A multicenter non-randomized confirmatory trial of stereotactic body radiation therapy for solitary lung tumor after complete resection of non-small cell lung cancer (JROSG17-4)
Scientific Title
A multicenter non-randomized confirmatory trial of stereotactic body radiation therapy for solitary lung tumor after complete resection of non-small cell lung cancer (JROSG17-4)
Scientific Title:Acronym
A multicenter non-randomized confirmatory trial of stereotactic body radiation therapy for solitary lung tumor after complete resection of non-small cell lung cancer (JROSG17-4)
Region
| Japan |
Condition
Condition
Solitary lung tumor within 3 years after complete resection of non-small cell lung cancer: patients with medically inoperable or refusing surgery: small lung lesion with the diameter of 3 cm or less
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of stereotactic body radiation therapy (SBRT) for solitary lung tumor within 3 years after complete resection of non-small cell lung cancer at multicenter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
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, severe adverse events
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
| Maneuver |
Interventions/Control_1
Stereotactic body radiation therapy 42 Gy/4 fractions
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Lung lesion with the diameter of 3 cm or less
2. Within 3 years after complete resection of non-small cell lung cancer (NSCLC)
3. Fulfilling the following conditions i) or ii) plus iii)
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/PET-CT
iii) Small cell lung cancer is excluded
4. Without lymph node metastasis and extrapulmonary metastasis with chest CT, FDG-PET/PET-CT, and enhanced cranial MRI
5. No lesion suspected of malignant tumor excluding pure-GGO
6. Aged 20-90 years old
7. ECOG performance status of 0-2
8. Fulfilling the dose constraints on radiation treatment planning
9. No previous thoracic radiotherapy for ipsilateral lung
10. Diagnosed as inoperable by board certified respiratory surgeon or refusing surgery
11. Sufficient organ functions; fulfilling all of the following conditions;
i) White blood cell >= 2000/mm3
ii) Hemoglobin >= 8.0 g/dL
iii) Platelet >= 30000/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%
12. Written informed consent
Key exclusion criteria
1. Lung lesion diagnosed as small cell lung cancer or large cell neuroendocrine cancer
2. Synchronous or metachronous malignancy within 3 years
3. Active infection requiring systemic therapy
4. Body temperature of 38 or more degrees Celsius
5. Woman during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding
6. Severe mental disease
7. Receiving continuous systemic steroid (more than 10mg/day of prednisolone) or immune-suppressive medication
8. Idiopathic pulmonary fibrosis on CT
9. Severe cough requiring narcortic drugs
10. Inappropriate patients for this study judged by physicians
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Nagata |
Organization
Hiroshima University
Division name
Hiroshima University
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-city
TEL
082-257-1545
nagat@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Takahashi |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
takahashi.shigeo@kagawa-u.ac.jp
Sponsor or person
Institute
Japanese Radiation Oncology Study Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Radiation Oncology Study Group
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
Ethics committee, Kagawa University Faculty of Medicine
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien@kagawa-u.ac.jp
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
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
災害医療センター（東京都）
山梨大学（山梨県）
静岡がんセンター（静岡県）
京都大学（京都府）
大阪公立大学（大阪府）
神戸市立医療センター中央市民病院（兵庫県）
兵庫県立がんセンター（兵庫県）
広島大学（広島県）
広島がん高精度放射線治療センター（広島県）
嬉野医療センター（佐賀県）
香川大学（香川県）
新潟県立がんセンター新潟病院（新潟県）
倉敷中央病院（岡山県）
四国がんセンター（愛媛県）
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044400
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