UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052016 |
|---|---|
| Receipt number | R000059378 |
| Scientific Title | Multi-institutional prospective registry of first-line chemoradiotherapy combined with hyperthermia for locally advanced non-small cell lung cancer (JSTM-NSCLC01LA). |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2023/08/27 21:28:46 |
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Basic information
Public title
Multi-institutional prospective registry of first-line chemoradiotherapy combined with hyperthermia for locally advanced non-small cell lung cancer (JSTM-NSCLC01LA).
Acronym
JSTM-NSCLC01LA
Scientific Title
Multi-institutional prospective registry of first-line chemoradiotherapy combined with hyperthermia for locally advanced non-small cell lung cancer (JSTM-NSCLC01LA).
Scientific Title:Acronym
JSTM-NSCLC01LA
Region
| Japan |
Condition
Condition
Locally advanced non-small cell lung cancer without distant metastases
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine treatment efficacy, adverse events and heating feasibility in hyperthermia combined with chemotherapy for locally advanced non-small cell lung cancer without distant metastases, using a multi-institutional, prospective registry of patient data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival rate
Key secondary outcomes
Overall survival rate, side effects
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. locally advanced non-small cell lung cancer, without distant metastases.
2. patients diagnosed with non-small cell lung cancer by tissue biopsy or cytology
3. overall condition (KPS: Karnofsky performance status) > 70
4. initial treatment
Key exclusion criteria
Active overlapping cancers (concurrent overlapping cancers and iatrogenic overlapping cancers with a disease-free period of five years or less). However, intraepithelial cancer, lesions equivalent to intramucosal cancer and skin cancer that are considered curable by local treatment are not included in active overlapping cancers.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ohguri |
Organization
University of Occupational and Environmental Health
Division name
Department of Therapeutic Radiology
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
TEL
0936031611
ogurieye@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Ohguri |
Organization
University of Occupational and Environmental Health
Division name
Department of Therapeutic Radiology
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
TEL
0936031611
Homepage URL
ogurieye@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
Tel
0936031611
ogurieye@med.uoeh-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 28 | 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
| 2023 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
data accumulation in progress
Management information
Registered date
| 2023 | Year | 08 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059378
