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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03802058
• Other study ID #: Nab-P RT
• Status: Terminated
• Phase: Phase 2
• Start date: March 20, 2019
• Est. completion date: December 12, 2021

Study information

• Verified date: April 2023
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nab-paclitaxel
Nab-paclitaxel 40mg/m2 for Injection weekly
• Carboplatin
Carboplatin AUC=2 for Injection weekly

Radiation:
• Thoracic radiation therapy
Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan University	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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