Study of Split-course Chemoradiotherapy For Postoperative Locoregional Recurrence Of Non-small Cell Lung Cancer

A Prospective, Randomized, Phase Ⅱ Study of Split-course Chemoradiotherapy For Locoregional Recurrence Of Non-small Cell Lung Cancer After Surgical Resection

This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection

This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection.

Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions and 15-24 Gy/5-8 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Inclusion Criteria:

• Pathologic confirmation of NSCLC.
• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Postoperative locoregional recurrence including ipsilateral hemithorax and the mediastinum.
• 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
• Forced expiratory volume at one second (FEV1) >0.8 L
• Coagulation tests 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
• Second primary carcinoma of the lung
• Contraindication for chemotherapy
• Malignant pleural or pericardial effusion.
• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dos
• 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