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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01494415
• Other study ID #: HZFH CA11-01
• Status: Recruiting
• Phase: Phase 2
• First received: December 14, 2011
• Last updated: December 13, 2015
• Start date: July 2012
• Est. completion date: June 2017

Study information

• Verified date: December 2015
• Source: First People's Hospital of Hangzhou
• Contact: Bing Xia, MD, PhD
• Phone: 86 18857110928
• Email: bxia_hzch[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: June 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Paclitaxel for Injection(Albumin Bound)
concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks
• carboplatin
concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks

Radiation:
• thoracic radiation therapy
66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang
China	The First People's Hospital of Hangzhou	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response rate		one month after the end of all treatment	Yes
Secondary	progression-free survival		2 years from patient enrollment	Yes
Secondary	overall survival		2 years from patient enrollment	Yes
Secondary	esophagitis	acute esophagitis of Grade III and above	6 mouths from the initiation of treatment	Yes