Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03802058|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma||Drug: Nab-paclitaxel Drug: Carboplatin Radiation: Thoracic radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer|
|Actual Study Start Date :||March 20, 2019|
|Estimated Primary Completion Date :||May 6, 2022|
|Estimated Study Completion Date :||November 6, 2022|
Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
Nab-paclitaxel 40mg/m2 for Injection weekly
Other Name: Nab-P
Carboplatin AUC=2 for Injection weekly
Other Name: CBP
Radiation: Thoracic radiation therapy
Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
Other Name: RT
- PFS (progression-free survival ) [ Time Frame: 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.
- ORR (Overall Response Rate ) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802058
|Contact: Conghua Xie, Drfirstname.lastname@example.org|
|Contact: Wen Ouyang, Dremail@example.com|
|Zhongnan Hospital of Wuhan University||Recruiting|
|Wuhan, Hubei, China, 430071|
|Contact: Conghua Xie, Dr 0086-27-67812607 firstname.lastname@example.org|
|Contact: Wen Ouyang, Dr 0086-27-67812607 email@example.com|
|Principal Investigator: Conghua Xie, Dr|
|Sub-Investigator: Wen Ouyang, Dr|
|Principal Investigator:||Conghua Xie, Dr||Wuhan University|