Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNab-paclitaxel
Nab-paclitaxel 40mg/m2 for Injection weekly
DRUGCarboplatin
Carboplatin AUC=2 for Injection weekly
RADIATIONThoracic radiation therapy
Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Wuhan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 Years to 70 Years * Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale. * Previously untreated, histological documented, inoperable stage III squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes. * Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields. * Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study. * Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug. * Patients must sign a study-specific informed consent form prior to study entry.
Exclusion criteria
* Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery. * Previous chemotherapy or previous biologic response modifiers for current lung cancer. * Patient has previously had thoracic radiation therapy. * Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more. * Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator. * History of significant neurological or mental disorder, including seizures or dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS (progression-free survival ) | 5 years from patient enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR (Overall Response Rate ) | one month after the end of all treatment | 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. |
| LCR (Local Control Rate) | one month after the end of all treatment | The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD). |
| OS (Overall survival) | 5 years from patient enrollment | Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method. |
| Number of participants with adverse events as assessed by CTCAE v4.0 | 5 years from patient enrollment | The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02. |
| Patient quality of life (QOL) | 5 years from patient enrollment | 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. |
Countries
China
Outcome results
None listed