UMIN-CTR Clinical Trial

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
Email	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
Email	yminegis@nms.ac.jp

Sponsor
Institute	Specified Nonprofit Corporation North East Japan Study Group
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041322