Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, Split-course Chemoradiotherapy, Locoregional recurrence, Postoperative recurrence
Brief summary
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
Detailed description
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.
Interventions
RADIATIONsplit-course radiotherapy
split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f
DRUGconcurrent chemotherapy
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 2 years |
| Response Rate | 2 years |
| rate of patients who develop local recurrence or distant recurrence | 2 year |
| rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0 | 1 year |
Countries
China
Contacts
Primary ContactBo Qiu, attending
Outcome results
None listed