UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036280 |
|---|---|
| Receipt number | R000041322 |
| Scientific Title | Multi-institutional retrospective study for advanced lung cancer patients with end-stage kidney disease on hemodialysis (NEJ-042) |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/09/24 12:21:30 |
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Basic information
Public title
Surveillance of chemotherapy in lung cancer patients on hemodialysis
Acronym
NEJ-042 study
Scientific Title
Multi-institutional retrospective study for advanced lung cancer patients with end-stage kidney disease on hemodialysis (NEJ-042)
Scientific Title:Acronym
NEJ-042 study
Region
| Japan |
Condition
Condition
advanced lung cancer patients with end-stage kidney disease on hemodialysis
Classification by specialty
| Pneumology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of chemotherapy for patients with this condition
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of severe adverse event
Key secondary outcomes
overall survival
objective response rate
time to treatment failure
frequency of each adverse events
type of anti-cancer drugs
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. histologically or cytologically confirmed lung cancer
2. Ineligible for surgery and curative radiotherapy due to cancer status
3. Complicated with end-stage renal failure on hemodialysis
Key exclusion criteria
Patient, or family refuses to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Seike |
Organization
Nippon Medical School Hospital
Division name
pulmonary medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
mseike@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Minegishi |
Organization
Nippon Medical School Hospital
Division name
Department of Medical Oncology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
yminegis@nms.ac.jp
Sponsor or person
Institute
Specified Nonprofit Corporation North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
Specified Nonprofit Corporation North East Japan Study Group
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
Nippon Medical School Hospital Research ethics committee
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
app-ccr@nms.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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0169500222005499?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0169500222005499?via%3Dihub
Number of participants that the trial has enrolled
162
Results
Chemotherapy should be considered for hemodialysis patients with EGFR-mutant NSCLC and SCLC. However, the survival benefits of chemotherapy for NSCLC patients with EGFR-wild type are unclear; physicians should carefully consider whether to offer chemotherapy to this patient subset.
Results date posted
| 2022 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 26 | Day |
Baseline Characteristics
Sixty-seven patients had not received any systemic chemotherapy regardless of cancer stage and their condition, and 91 patients had received chemotherapy alone or chemoradiotherapy. The primary causes of renal failure were diabetic nephropathy and hypertensive nephrosclerosis. The median age of initiation of HD and duration of HD were 67 (range, 24-86) and 4.0 (range, 0.1-41) years, respectively. Patients in the BSC group were significantly older, had more ECOG performance status (PS) 3-4, fewer small cell carcinomas, and fewer EGFR mutant than those in the chemotherapy group. We therefore inferred that age, PS, histology, and status of driver oncogenes might influence decision making. Despite the curative stage (I-IIIA), up to 18 % of patients had not been offered any of the standard anticancer treatments such as surgery or radiotherapy.
Participant flow
This multicenter retrospective study was conducted by the North-East Japan Study Group with clinical investigators from 22 institutions in Japan. We consecutively enrolled patients undergoing HD who were diagnosed with lung cancer after the initiation of dialysis in each participating institution from January 2002 to June 2018.
Adverse events
The safety profile of cytotoxic chemotherapy was predominantly myelosuppression with high frequency of FN compared to non-HD patients, but there was no increased TRD. Although 26 patients (35%) discontinued the planned chemotherapy, and half of these did so fir reasons unrelated to disease progression or AEs. We infer that the exacerbation of general conditions due to comorbidity and frailty associated with HD may underlie the discontinuation of chemotherapy.
Outcome measures
In small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) patients who received cytotoxic chemotherapy, the objective response rates (ORR) and median overall survival (OS) were 68.1 %, 12.3 months and 37.0 %, 8.5 months, respectively. The ORR and median OS in patients with EGFR-mutant NSCLC treated with EGFR-tyrosine kinase inhibitors (TKI) were 44.4 % and 38.6 months. The treatment-related adverse events (Grade 3 or higher) induced by cytotoxic chemotherapy were myelosuppression and febrile neutropenia; treatment-related death (TRD) was observed in one patient. TRD occurred in 3 of 18 patients who received EGFR-TKI.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-institutional retrospective study
Management information
Registered date
| 2019 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041322
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