UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056263 |
|---|---|
| Receipt number | R000064248 |
| Scientific Title | Multicenter, retrospective, observational study of chemotherapy for recurrence after chemoradiation and durvalumab consolidation therapy for unresectable locally advanced non-small cell lung cancer.TORG-TG2402 |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/11/28 00:57:59 |
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Basic information
Public title
Multicenter, retrospective, observational study of chemotherapy for recurrence after chemoradiation and durvalumab consolidation therapy for unresectable locally advanced non-small cell lung cancer.TORG-TG2402
Acronym
Retrospective, observational study of chemotherapy for recurrence after the PACIFIC regimen for unresectable locally advanced NSCLC, TORG-TG2402
Scientific Title
Multicenter, retrospective, observational study of chemotherapy for recurrence after chemoradiation and durvalumab consolidation therapy for unresectable locally advanced non-small cell lung cancer.TORG-TG2402
Scientific Title:Acronym
Retrospective, observational study of chemotherapy for recurrence after the PACIFIC regimen for unresectable locally advanced NSCLC, TORG-TG2402
Region
| Japan |
Condition
Condition
Patient with unresectable locally advanced non-small cell lung cancer who relapsed after chemoradiotherapy and durvalumab consolidation therapy.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will retrospectively compare the efficacy and safety of platinum-based chemotherapy with or without immune checkpoint inhibitors as initial chemotherapy after recurrence of chemoradiotherapy and durvalumab consolidation therapy for unresectable locally advanced non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival (PFS) for initial chemotherapy after relapse: A survival curve will be estimated using the Kaplan-Meier method, and the median PFS and its 95% confidence interval will be calculated. To adjust for background factors, multivariate Cox regression models and propensity score matching will be used to compare groups.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with NSCLC diagnosed by cytology or histology.
(2) Patients with unresectable local progression or postoperative local recurrence.
(3) Patients who have undergone radical CRT and at least one course of durvalumab consolidation therapy.
(4) Patients who received platinum plus ICI or platinum combination therapy for recurrence from July 2, 2018 to June 30, 2023.
Key exclusion criteria
(1) Patients who had prior irradiation of all recurrent lesions.
(2) Patients who were judged to be inappropriate for this study by the physician of information collection at each institution.
(3) Patients with driver gene mutation (EGFR, ALK, ROS1, MET exon 14 skipping, RET, BRAF) positive.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Katakura |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
2410815
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
TEL
0455202222
shetland1015@gmail.com
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Katakura |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
2410815
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
TEL
0455202222
Homepage URL
shetland1015@yahoo.co.jp
Sponsor or person
Institute
Cancer and Infectious Disease Center Tokyo Metropolitan Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
Tel
0455202222
clinical_trials@kcch.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 | 11 | Month | 25 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064248
