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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041879 |
Receipt No. | R000047797 |
Scientific Title | Safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer in the real-world setting. |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2020/09/24 |
Basic information | ||
Public title | Safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer in the real-world setting. | |
Acronym | SERIAL study | |
Scientific Title | Safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer in the real-world setting. | |
Scientific Title:Acronym | SERIAL study | |
Region |
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Condition | |||
Condition | Lung Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Examine the safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Safety(Grade 3 or higher non-hematological toxicity ) |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Age of 20 years old or older
2) Advanced or postoperative recurrence small cell lung cancer 3) Intracranial radiation therapy is planned within 8 weeks after or during the platinum doublet + ICI therapy, or ICI maintenance therapy 4) Consent is obtained in writing regarding participation in this study |
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Key exclusion criteria | 1) The cases which the attending physician has determined ineligible | |||
Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chiba University Hospital | ||||||
Division name | Department of Respirology | ||||||
Zip code | 260-8677 | ||||||
Address | 1-8-1, Inohana, Chuo-ku, Chiba, Japan | ||||||
TEL | 043-226-2575 | ||||||
iwasawas@chiba-u.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saiseikai Suita Hospital, Osaka | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | 564-0013 | ||||||
Address | 1-2, Kanazono-cho, Suita, Osaka, Japan | ||||||
TEL | 06-6382-1521 | ||||||
Homepage URL | |||||||
aska_517@icloud.com |
Sponsor | |
Institute | Chiba University |
Institute | |
Department |
Funding Source | |
Organization | Chiba University |
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 | Research ethics committee of the graduate school of medicine, Chiba university |
Address | 1-8-1 Inohana Chuo-ku, Chiba |
Tel | +81-43-222-7171 |
inohana-rinri@chiba-u.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Evaluate the safety of intracranial radiotherapy under immunotherapy against CNS metastases examining the Grade 3 or higher non-hematological toxicity
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047797 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |