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The study was halted because enrollment was too slow
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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel | Experimental | Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel | Drug | Nab-paclitaxel 40mg/m2 for Injection weekly |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conghua Xie, Dr | Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
all IPD can be shared by all researchers who participate in this study by e-mail contact
2 years after the end of the study
Researchers who participate in this study
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Carboplatin | Drug | Carboplatin AUC=2 for Injection weekly |
|
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| Thoracic radiation therapy | Radiation | Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed |
|
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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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |