The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer

The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer - LOGIK1304

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014923

Enrollment

300

Registered

2014-08-22

Start date

2016-01-14

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 histologically confirmed NSCLC 2) Patients with above pathological stage IB and complete resection (including R0 (un)) 3) Patients with no prior treatment of chemotherapy or radiation therapy on NSCLC 4) Patients that are able to treat adjuvant chemotherapy within 8 weeks 5) Patients with more than 60% of Karnofsky Performance Status at the registration 6) Age >=75 years (at the registration) 7) Written informed consent 8) patients with adequate organ function (within 2 weeks before registration): 1.Neutrophils >=3500 /mm3 <12000/mm3 2.Platelet >= 100000/mm3 3.Hemoglobin >= 9.0g/dL 4.AST and ALT < 2 x ULN 5.Total bilirubin < 1.5 mg/dl 6.Serum creatinine <= 1.2 mg/dl 7. PaO2>= 60 Torr or SpO2 >= 92%

Exclusion criteria

Exclusion criteria: 1) Patients with incomplete resection of NSCLC 2) Patients with past history of severe drug allergy 3) Patients with clinically problematic active severe complications 4) Patients with active concomitant malignancy in another organs 5) Any other patients who are regarded as unsuitable for this study by the investigators

Design outcomes

Primary

Measure	Time frame
Baseline change of Karnofsky Performance status score	—

Countries

Japan

Contacts

Public ContactSeiichi Fukuyama

National Hospital Organization Beppu Medical Center Department of Respiratory Surgery

sfukuyam@beppu2.hosp.go.jp0977-67-1111

Outcome results