UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018253 |
|---|---|
| Receipt number | R000021040 |
| Scientific Title | Observational study to evaluate effectiveness of prophylactic cranial irradiation on patients with limited-stage small cell lung cancer. |
| Date of disclosure of the study information | 2015/07/16 |
| Last modified on | 2018/07/11 21:55:40 |
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Basic information
Public title
Observational study to evaluate effectiveness of prophylactic cranial irradiation on patients with limited-stage small cell lung cancer.
Acronym
Observational study of PCI on LS-SCLC
Scientific Title
Observational study to evaluate effectiveness of prophylactic cranial irradiation on patients with limited-stage small cell lung cancer.
Scientific Title:Acronym
Observational study of PCI on LS-SCLC
Region
| Japan |
Condition
Condition
Limited-stage small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of prophylactic cranial irradiation in patients with limited stage small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of brain metastasis
Key secondary outcomes
Overall survival time, Quality of life (QCQ-C30/BN20), cognitive ability (MMSE)
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
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 or cytologically confirmed small cell lung cancer in limited-stage (IA to IIIB)
2. Responded to first treatment to complete response or good partial response (short axis of all mediastinal lymphnodes <15mm, no persisting primary lesion)
3. Confirmed absence of brain metastasis with enhanced cranial MRI within 2 months after the finish of initial treatment
Key exclusion criteria
1. Patients with brain metastasis
2. Patients judged as inappropriate for this study by investigators
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of Internal Medicine, second division
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | koji Nishimoto |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of Internal Medicine, second division
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
Homepage URL
knishi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu Shizuoka Respiratory Group
Institute
Department
Personal name
Funding Source
Organization
Seirei Mikatahara General Hospital
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
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
| 2015 | Year | 07 | Month | 16 | 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 | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cranial MRI: Every 3 months for first 2 years and every 6 months after that.
QOL (QCQ-C30/BN20), cognitive ability: Every 6 months for first 1 year and every 12 months after that.
Management information
Registered date
| 2015 | Year | 07 | Month | 09 | Day |
Last modified on
| 2018 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021040
