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

Phase 2

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma
• Interventions: Drug: Nab-paclitaxel; Drug: Carboplatin; Radiation: Thoracic radiation therapy

• Registration Number: NCT03802058
• Lead Sponsor: Wuhan University

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.

Study Timeline

• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-14
• Study Start: 2019-03-20
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nab-paclitaxel	Nab-paclitaxel	Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
Nab-paclitaxel	Carboplatin	Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
Nab-paclitaxel	Thoracic radiation therapy	Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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).

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China