Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer

Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer - Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019611

Enrollment

Registered

2015-11-02

Start date

2013-08-30

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

Concurrent chemoradiotherapy (radiotherapy 60Gy (2Gy/day) /6week, carboplatin AUC2, day1, 8, 15, 22, 29, 36 + nab-paclitaxel 40mg/m2, day1, 8, 15, 22, 29, 36) followed by consolidation chemotherapy (c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient with histologically or cytologically confirmed NSCLC 2. Patient with measurable lesions 3. Clinical stage IIIA/B 4. V20 of the lung <=40%, based on CT-simulation 5. Patient without the treatment history of chemotherapy, radiotherapy and surgery for NSCLC 6. Performance Status (Eastern Cooperative Oncology Group: ECOG) 0-1 7. 20 years old or older, younger than 80 8. Patient without metastasis, diagnosed with contrast-enhanced CT of the chest and abdomen, bone scintigrapy, contrast-enhanced head CT or head MRI 9. Adequate organ function: WBC >=3000/mm3 Neutrophil count >= 1,500 /mm3 Hemoglobin >= 9.0 g/dL Platelet count >= 100,000 /mm3 Total bilirubin <= 1.5 mg/dL AST <= twice of ULN ALT <= twice of ULN Serum creatinine <= 1.5 mg/dL PaO2 >= 60mmHg 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patient with a history of allergy to taxane antineoplastic agents 2. Patient with a history of allergy to carboplatin or other platinum-based antineoplastic agents 3. Patient with a history of allergy to albumin 4. without the concent to the risk of infection caused by albumin preparation 5. Patients with active infection 6. Patients with serious complications (e.g. heart failure, severe pulmonary emphysema, renal disfunction, hepatic disfunction, poorly controlled diabetes or hypertension) 7. Patient with severe bone marrow suppression 8. Patient with active double cancer within 5years prior to the study 9. Patients with pleural or pericardial effusion, or ascites. 10. Patient with motor paralysis or neuropathy, except due to NSCLC 11. Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest radiograph 12. Patient with collagen vascular diseases 13. Female Patient in or having a chance or planning of pregnancy or breast feeding 14. Male patient in planning to impregnate 15. Inappropriate patients for this study judged by the attending physician

Design outcomes

Primary

Measure	Time frame
Responce Rate	—

Secondary

Measure	Time frame
Completion rate of the protocol treatment, Progression Free Survival, Overall Survival, Safety, Relative Dose Intensity	—

Countries

Japan

Contacts

Public ContactKeiko Shibuya

Yamaguchi University Hospital Department of Radiation Oncology

kshibuya@yamaguchi-u.ac.jp0836-22-2966

Outcome results

None listed

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