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. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.

Detailed Description
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This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.

Official Title
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A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer

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

Intervention / Treatment
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* Drug: Paclitaxel for Injection（Albumin Bound）
* Drug: carboplatin
* Radiation: thoracic radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale. Previously untreated, histological documented, inoperable stage IIIA or IIIB 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. Weight loss ≦ 5% in the previous six months. 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: 75 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: chemoradiotherapy<br>This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy. | Drug: Paclitaxel for Injection（Albumin Bound）<br>* concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks<br>* Other names: Abraxane®;Drug: carboplatin<br>* concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks<br>Radiation: thoracic radiation therapy<br>* 66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response rate |  | one month after the end of all treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years from patient enrollment | 
| overall survival |  | 2 years from patient enrollment | 
| esophagitis | acute esophagitis of Grade III and above | 6 mouths from the initiation of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous Cell Lung Cancer, radiation therapy, chemotherapy