Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804)

Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804) - Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043937

Enrollment

800

Registered

2021-04-16

Start date

2019-01-22

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)Non-small cell lung cancer 2)Tumor size >2cm 3)R0 4)Standard surgical treatment was performed 5)Lymph node dissection or Lymph node sampling were performed 6)No treatment prior to surgery 7)Performance status (ECOG) 0-1 8)Sufficient organ function (Bone marrow, Liver, Kidney, Lung) 9)Within 56 days after surgery

Exclusion criteria

Exclusion criteria: 1) The patients had tumors where genetic testing cannot be performed for some reason (insufficient sample volume, etc. 2) Active double cancer, excluding the following curable cases even if the disease-free period is within 5 years; carcinoma in situ or mucosal cancer, prostate cancer (stage I), gastric cancer (stage 0-I), colorectal cancer (stage 0-I), esophageal cancer (stage 0), breast cancer (stage 0), thyroid cancer (papillary or follicular cancer, stage I-III), renal cancer (clear cell carcinoma or chromophobe cell cancer, stage I). 3) The patients were dead within 30 days after surgery. 4) The patients were pregnant or breastfeeding, and the patients may be pregnant, or will be pregnant, or willing to get pregnant. 5) The patients were difficult to participate in the study because of psychosis and/or mental illness. 6) The patients had grade 3 or higher adverse events 7) The attending physician judged that it was inappropriate for the patient to participate in the study. 8) The patients refused to participate in the study.

Design outcomes

Primary

Measure	Time frame
3 year and 5 year disease free survival survival after surgery	—

Secondary

Measure	Time frame
1)3 year and 5 year overall survival after surgery 2)Adjuvant chemotherapy implementation rate 3)Outcomes by genetic mutation or PD-L1 expression	—

Countries

Japan

Contacts

Public ContactYUICHI SAITO

Teikyo University School of Medicine Department of Surgery

k3699004@gmail.com03-3964-1211

Outcome results