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

Phase 2

• Conditions: Carcinoma, Squamous Cell; Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Paclitaxel for Injection（Albumin Bound）; Drug: carboplatin; Radiation: thoracic radiation therapy

• Registration Number: NCT01494415
• Lead Sponsor: First People's Hospital of Hangzhou

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. 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

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.

Study Timeline

• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Study Start: 2012-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-13
• Last Update Posted: 2015-12-15
• Primary Completion: 2016-07
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy	Paclitaxel for Injection（Albumin Bound）	This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
chemoradiotherapy	carboplatin	This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
chemoradiotherapy	thoracic radiation therapy	This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.

Primary Outcome Measures

Name	Time	Method
tumor response rate	one month after the end of all treatment

Secondary Outcome Measures

Name	Time	Method
progression-free survival	2 years from patient enrollment
overall survival	2 years from patient enrollment
esophagitis	6 mouths from the initiation of treatment	acute esophagitis of Grade III and above

Trial Locations

Locations (2)

The First People's Hospital of Hangzhou; 🇨🇳 Hangzhou, Zhejiang, China

Hangzhou Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China