UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049194 |
|---|---|
| Receipt number | R000055943 |
| Scientific Title | Multicenter retrospective study evaluating the efficacy and safety of durvalumab after chemoradiotherapy for locoregional recurrence of completely resected non-small cell lung cancer. |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2023/04/13 14:50:16 |
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Basic information
Public title
Multicenter retrospective study evaluating the efficacy and safety of durvalumab after chemoradiotherapy for locoregional recurrence of completely resected non-small cell lung cancer.
Acronym
NEJ056
Scientific Title
Multicenter retrospective study evaluating the efficacy and safety of durvalumab after chemoradiotherapy for locoregional recurrence of completely resected non-small cell lung cancer.
Scientific Title:Acronym
NEJ056
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the progression free survival (PFS) from the time of initiation of chemoradiotherapy (CRT) in durvalumab after CRT group (CRT-D group) versus CRT group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS from the time of initiation of CRT.
Key secondary outcomes
2-year PFS rate and 2-year survival rate from the time of initiation of CRT. 2-year PFS rate and 2-year survival rate from the start date of durvalumab treatment. Objective Response rate (ORR) for CRT and Durvalumab. Safety during and after CRT.
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) Patients with NSCLC who were diagnosed with locoregional recurrence after surgical resection.
(2)Patients undergoing complete resection (Pneumonectomy/bilobectomy/ lobectomy/segmentectomy) and radical resection with ND2a-1 or higher-level lymph node dissection.
(3)Locoregional recurrence after complete surgical resection as recurrence only at the local site (the bronchial stump and adjacent areas) or also in the regional lymph node (ipsilateral hilar lymph nodes, mediastinal lymph nodes, and supraclavicular lymph nodes). Recurrence in the contralateral hilar lymph nodes and separate tumor nodule(s) in a different ipsilateral lobe were labeled as distant metastases and not included as locoregional recurrences. Postoperative recurrence was confirmed by one or both of computed tomography (CT) and 18F-fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT). Histopathologic diagnosis (biopsy) is not required.
(4) Patients with locoregional recurrences who had been treated for initial treatment by CRT containing platinum-based regimen followed by durvalumab (CRT-D group) or by CRT containing platinum-based regimen only (CRT group). Platinum-based chemotherapy must administered for at least 2 cycles. Patients must have received a total dose of radiation of 54 to 66 Gy.
(5) Chemoradiotherapy must have been started between January 1, 2016 and December 31, 2020.
(6) Patients who have not progressed following CRT in initial assessment.
(7) In CRT group, patients must have received at least one dose of Durvalumab.
(8) In CRT group, radiotherapy must have been completed by April 30, 2018.
(9) Age of > 20 years at the start of CRT.
(10)Patients for which survival and treatment information for postoperative recurrence information can be collected.
(11)Patients who have not refused to participate in this study.
Key exclusion criteria
(1) Patients diagnosed as having small-cell lung cancer (SCLC), combined SCLC, large-cell neuroendocrine carcinoma.
(2) In both groups, patients do not meet the eligibility criteria for Durvalumab (e.g. active autoimmune disease, grade 2 or higher pneumonitis from previous CRT)
(3)Patients with distant metastases at diagnosis of recurrence or at initial evaluation after chemoradiotherapy.
(4)Other cases that are determined to be inappropriate by attending physicians.
(5)Patients with active multiple cancers.
(6) Receipt of any investigational new drugs for post-treatment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Asahina |
| Middle name | |
| Last name | Hajime |
Organization
Hokkaido University Graduate school of Medicine
Division name
Department of Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Japan
TEL
011-706-5911
asahinah@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Furuta |
Organization
Hokkaido University Graduate school of Medicine
Division name
Department of Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Japan
TEL
011-706-5911
Homepage URL
furutamegumi@huhp.hokudai.ac.jp
Sponsor or person
Institute
North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2022 | Year | 10 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055943
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