Prospective observational study assessing the relationship between adverse events in chemotherapy for older lung cancer patients.

ENSURE-GA2 study - ENSURE-GA2 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053395

Enrollment

400

Registered

2024-01-19

Start date

2024-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with untreated stage IV or post-operative recurrence who was histologically or cytologically confirned as non-small-cell lung cancer (2)ECOG performance status (PS) : 0-3 (3)Written informed concent

Exclusion criteria

Exclusion criteria: (1)Patients with dimentia (2)Patients with psychiatric disorder (3)Any other patients who are regarded as unsuitable for this study by the investigators

Design outcomes

Primary

Measure	Time frame
Comparison of the proportion of patients who experienced CTCAE v5.0 grade 2 or higher adverse events (non-hematologic toxicity) and the proportion of patients whose IADL decreased by one or more items before and after treatment	—

Secondary

Measure	Time frame
Relationship between the results of risk assessment conducted before drug therapy and the actual occurrence of adverse events (examined for each cytotoxic anticancer drug, molecular target drug, and immune checkpoint inhibitor) Treatment completion rate ECOG PS improvement rate of 1 level or more Comparison of the proportion of patients who experienced CTCAE v5.0 grade 2 or higher adverse events and the proportion of patients whose Geriatric 8 score decreased by 1 or more points before and after treatment	—

Measure

Time frame

Relationship between the results of risk assessment conducted before drug therapy and the actual occurrence of adverse events (examined for each cytotoxic anticancer drug, molecular target drug, and immune checkpoint inhibitor) Treatment completion rate ECOG PS improvement rate of 1 level or more Comparison of the proportion of patients who experienced CTCAE v5.0 grade 2 or higher adverse events and the proportion of patients whose Geriatric 8 score decreased by 1 or more points before and after treatment

—

Countries

Japan

Contacts

Public ContactYukari Tsubata

Department of Internal Medicine, Shimane University Faculty of Medicine Division of Medical Oncology & Respiratory Medicine

ytsubata@med.shimane-u.ac.jp+81-853-20-2580

Outcome results