A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer

A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer - A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029435

Enrollment

Registered

2017-10-10

Start date

2017-10-10

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

Combination treatment with carboplatin (AUC = 5),Day1,29 + Nab-PTX(80mg/m2), Day1, 8, 15, 29, 36, 42. Radiation therapy

started once a day 1.8 Gy from Day 1, 25 times in total, 45 Gy. Resection more than lobectomy with mediastinal lymph node dissection of ND2a or more. Combination treatment with carboplatin (AUC =

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed stage IIIA, N2, non-small cell lung cancer 2. 20 or older at registration 3. ECOG PS of 0-1 4. Without receiving cytotoxic agents chemotherapy or chest radiotherapy 5.Complete resection can be expected by lobectomy after introduction chemoradiotherapy 6.Postoperative prediction FEV 1.0 <800 ml 7. Adequate organ function Neutrophil cout of more than 1,500/mm3 Hemoglobin cout of more than 9.0g/dL Platelet cout of more than 100,000/mm3 Aspartate transaminase (AST), alanine tran Serum albumin: more than 3.0g/dL saminase(ALT): less than 100IU/L Total bilirubin: less than 2.0mg/dL Serum creatinine of less than 1.5mg/dL SpO2 of more than 94%

Exclusion criteria

Exclusion criteria: 1. History of severe hypersensitivity to taxane group 2. History of severe hypersensitivity to Carboplatin 3. History of severe hypersensitivity to albumin preparation 4. Interstitial lung disease or pulmonary fibrosis 5. Severe infectious disease or severe uncontrolled complication 6. Active malignancy of other organ 7. HBs antigen positive

Design outcomes

Primary

Measure	Time frame
2 year recurrence-free survival rate	—

Secondary

Measure	Time frame
Recurrence-free survival time Overall survival time Accomplish treatment rate Response rate of introduction chemoradiotherapy Safety	—

Countries

Japan

Contacts

Public ContactToshihide Yokoyama

Kurashiki Central Hospital Department of respiratory medicine

y14401@kchnet.or.jp086-422-0210

Outcome results

None listed

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