UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054100 |
|---|---|
| Receipt number | R000061787 |
| Scientific Title | Development of a Scoring Model to Predict Completion of Chemoradiotherapy for Inoperable Stage III NSCLC |
| Date of disclosure of the study information | 2024/04/10 |
| Last modified on | 2024/04/10 10:12:09 |
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Basic information
Public title
Development of a Scoring Model to Predict Completion of Chemoradiotherapy for Inoperable Stage III NSCLC
Acronym
Scoring Model to Predict Completion of Chemoradiotherapy for Stage III NSCLC
Scientific Title
Development of a Scoring Model to Predict Completion of Chemoradiotherapy for Inoperable Stage III NSCLC
Scientific Title:Acronym
Scoring Model to Predict Completion of Chemoradiotherapy for Stage III NSCLC
Region
| Japan |
Condition
Condition
Inoperable Stage III Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a scoring model to predict completion of chemoradiotherapy for inoperable stage III NSCLC.
Basic objectives2
Others
Basic objectives -Others
To evaluate the percentage of treatment completion, best overall response, progression-free survival, overall survival, best overall response, and duration of treatment success for each score in the developed scoring model.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of treatment completed = Percentage of protocol treatment completed for each study
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
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
The study will include 1288 patients enrolled in the CRT dataset stored in the Japan Lung Cancer Society Integrated Database of Clinical Trials (JIDB).
The following cases are selected from JIDB.
(1) Patients who received concurrent radiation and chemotherapy
(2) Patients who were diagnosed with unresectable locally advanced non-small cell lung cancer
Key exclusion criteria
Exclude the following cases.
(1) Cases in which completion of treatment was not noted.
Target sample size
1288
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Department of Internal Medicine, Second Devision
Zip code
4313192
Address
Hanadayama 1-20-1, Hamamatsu, Shizuoka
TEL
0534352263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Karayama |
Organization
Hamamatsu University School of Medicine
Division name
Cancer Center
Zip code
4313192
Address
Hanadayama 1-20-1, Hamamatsu, Shizuoka
TEL
053-435-2491
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Clinical Research Ethics Committee, Hamamatsu University School of Medicine
Address
Hanadayama 1-20-1, Hamamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.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
| 2024 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will use JIDB, an integrated database of clinical research that integrates multiple randomized controlled trials collected at the Japanese Lung Cancer Association. The main objective of this study is to construct a scoring model related to treatment completion.
1. Overall survival, progression-free survival, and duration of treatment success: Survival curves will be estimated for each score in the constructed scoring model using the Kaplan-Meier method. Also, depict Kaplan-Meier plots. Based on the estimated survival curves, calculate the 95% confidence intervals for the median survival period and annual survival rate based on Greenwood's formula. The double log transformation is used to calculate the confidence intervals. In addition, we will evaluate the propensity in the scoring model constructed using the log-rank trend test, and calculate the hazard ratio and 95% confidence interval for the group with each score relative to the group with the lowest score.
2. Best overall effect: Summarize the overall best effect (CR, PR, SD, PD, NE) in each score of the constructed scoring model. The response rate and disease control rate for the best overall effect will be summed for each group, and the exact 95% confidence interval for Clopper-Pearson will be calculated. We will also evaluate the propensity in the scoring model constructed using the Cochran-Armitage test, and calculate the odds ratio and 95% confidence interval for the group with each score relative to the group with the lowest score.
3. Evaluation of safety: Adverse events in each score of the constructed scoring model are summarized in terms of frequency and percentage for each event. In addition, the frequency, incidence rate, and Clopper-Pearson exact 95% confidence interval of adverse events of Any grade, G3 or higher, and G4 or higher will be calculated.
Management information
Registered date
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061787
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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