Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Chest Wall: A Phase II Trial

Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Chest Wall: A Phase II Trial - Chemoradiotherapy Followed by Surgery in Treating Patients With Non-Small Cell Lung Cancer Involving the Chest Wall

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001810

Enrollment

Registered

2009-04-01

Start date

2009-03-01

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

Lung Cancer

Interventions

Patients receive chemotherapy consisted of Cisplatin 80 mg/m2 day 1 + Vinorelbine 20 mg/m2 days 1 and 8 / 4 weeks x 2 courses Patients receive also concurrent radiotherapy (Radiation field: Primary

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically and/or cytologically confirmed non-small cell lung cancer 2.Resectable T3N0-1M0 lung cancer with chest wall invasion including superior sulcus tumor Criteria for chest wall invasion: # The tumor obviously invades the soft tissue of the chest wall or ribs at CT. # The tumor is contiguous to the chest wall at CT, and chest pain and/or positive findings of bone scintigraphy is present at the primary site. 3.No prior therapy 4.Measurable lesions 5.Performance status (ECOG): 0-1 6.Hematopoietic: WBC >3500/ mm3, ANC >1500/ mm3, Hb >=10.0g/dl, Plt >=100000/ mm3 7.Hepatic: T-Bil <=1.5 mg/dl, AST/ALT <80 IU/L 8.Renal: Serum Cr <1.5 mg/dl, CCr >=60 ml/min 9.Pulmonary function: PaO2 >=70 Torr (room air), Predictive postoperative FEV1.0 >=800 ml 10.Written informed consent

Exclusion criteria

Exclusion criteria: 1.N2 disease: Obvious N2 disease at CT/PET, or histologically and/or cytologically confirmed N2 disease by mediastinoscopy and/or EBUS. 2.Active double cancer 3.Prior chemotherapy or radiotherapy 4.Patients with serious comobidities; serious cardiac complications such as uncontrollable angina, myocardial infarction within 3 months, heart failure, arrhythmia required treatment, uncontrollable diabetes mellitus and hypertion, definite interstitial pneumonina, lung fibrosis, and severe emphysema at CT, and infectious diseases. 5.Pregnant or nursing woman 6.V20 more than 30% of normal lung

Design outcomes

Primary

Measure	Time frame
Three-year survival	—

Secondary

Measure	Time frame
Completion rate and objective response rate of induction chemoradiotherapy, Adverse effects of induction chemoradiotherapy, Operability after induction chemoradiotherapy, Complete resection rate, Perioperative morbidity and mortality, Pathologic response, Recurrence patterns, Disease free survival, and Overall survival	—

Countries

Japan

Contacts

Public ContactKohei Yokoi

Nagoya University Graduate School of Medicine Department of Thoracic Surgery

k-yokoi@med.nagoya-u.ac.jp052-744-2376

Outcome results

None listed

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