Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.
This study was conducted to explore the efficacy and safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Nab-paclitaxel 40mg/m2 for Injection weekly
Carboplatin AUC=2 for Injection weekly
Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
PFS (progression-free survival )
PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.
Time frame: 5 years from patient enrollment
ORR (Overall Response Rate )
The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Time frame: one month after the end of all treatment
LCR (Local Control Rate)
The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).
Time frame: one month after the end of all treatment
OS (Overall survival)
Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
Time frame: 5 years from patient enrollment
Number of participants with adverse events as assessed by CTCAE v4.0
The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.
Time frame: 5 years from patient enrollment
Patient quality of life (QOL)
Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L).The total range of scores:0-144,and higher values represent a better outcome.
Time frame: 5 years from patient enrollment
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