Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Nab-paclitaxel
* Drug: Carboplatin
* Radiation: Thoracic radiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel<br>Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy | Drug: Nab-paclitaxel<br>* Nab-paclitaxel 40mg/m2 for Injection weekly<br>* Other names: Nab-P;Drug: Carboplatin<br>* Carboplatin AUC=2 for Injection weekly<br>* Other names: CBP;Radiation: Thoracic radiation therapy<br>* Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years from patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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. | 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. | 5 years from patient enrollment |