Split-course Thoracic Radiotherapy Combined With Nab-paclitaxel Plus Nedaplatin for Local Advanced NSCLC With Impaired Baseline Pulmonary Function

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This Phase II randomized study is to determine the efficacy of split-course thoracic radiotherapy combined with nab-paclitaxel plus nedaplatin for local advanced non-small cell lung cancer with severe impairment of baseline pulmonary function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Nedaplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Pathologic confirmation of NSCLC.

• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• Moderate to severe obstructive ventilatory dysfunction (FEV1.0/FVC≤60%), or / and moderate to severe restrictive ventilatory dysfunction(FEV1.0/FVC≤60%，TLC-SB（Act1/Pred）≤80%), or / and moderate to severe diffusion dysfunction (DLCOc/VA（Act1/Pred）≤60%).

• Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by EBUS.

• Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Previously treated with chemotherapy or treatment-naive

• No previous chest radiotherapy, immunotherapy or biotherapy

• Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL

• Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min

• Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL

• CB6 within normal limits

• patients and their family signed the informed consents

Exclusion Criteria:

• Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ

• Contraindication for chemotherapy

• Malignant pleural or pericardial effusion.

• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose

• Women who has the probability of pregnancy without contraception

• Tendency of hemorrhage

• In other clinical trials within 30 days

• Addicted in drugs or alcohol, AIDS patients

• Uncontrollable seizure or psychotic patients without self-control ability

• Severe allergy or idiosyncrasy

• Not suitable for this study judged by researchers