Phase II study of thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer

Phase II study of thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer - NHO0501

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002381

Enrollment

Registered

2009-08-26

Start date

2006-01-01

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

inoperable locally advanced stage IIIA/IIIB non-small cell lung cancer

Interventions

thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed non-small cell lung cancer Stage IIIA T1N2M0, T2N2M0, T3N2M0 Stage IIIB AnyTN3M0, T4AnyNM0 (Except for pulmonary atelectasis of a ipsilateral lung in T3,and malignant pleural effusion in T4) (Acceptable for contralateral mediastinal lymph node metastasis in N3. Except for contralateral hilar lymph node metastasis and contralateral and ipsilateral supraclavicular lymph node metastasis in N3) 2.No prior chemotherapy 3..measurable disease (2cm on chest CT) Eastern Cooperative Oncology Group performance status of 0 to 1 4.Age between 20 and 74 years 5.Adequate hematologic, hepatic, renal, and cardiac function WBC 4,000/microL Absolute neutrophil count 2,000/microL Platelet count 100,000/microL Hemoglobin 9.5 g/dL AST and ALT 2 times upper limit of normal Total bilirubin 1.5mg/dL Creatinine upper limit of normal Creatinine clearance 60mL/min PaO2 70 torr 6.Life expectancy more than 3 months 7.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Infections 2.Apparent interstitial pneumonitis or fibrosis on chest CT 3.Irradiation field larger than half of a ipsilateral lung 4.Ileus 5.Neuropathy (motor, sensory) 6.Severe complications(liver cirrhosis, diabetes mellitus, Clinically significant heart disease, etc.) 7.Myocardial infarction within the last 6 months 8.Another active cancer 9.Pregnancy, intent to become pregnant, or breast-feeding 10.Other non eligible cases judged by investigators

Design outcomes

Primary

Measure	Time frame
tumor response	—

Secondary

Measure	Time frame
safety, survival	—

Countries

Japan

Contacts

Public ContactTomoya Kawaguchi

NHO Kink-chuo Chest Medical Center Internal medicine

t-kawaguchi@kch.hosp.go.jp072-252-3021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026