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

NCT01494415 | Unknown Phase 2 DMC

• 1 other identifier: HZFH CA11-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Squamous Cell Lung Cancer; radiation therapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• tumor response rate

  one month after the end of all treatment

Secondary Outcomes (3)

• progression-free survival

  2 years from patient enrollment

• overall survival

  2 years from patient enrollment

• esophagitis

  6 mouths from the initiation of treatment

Study Arms (1)

chemoradiotherapy

EXPERIMENTAL

This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.

Drug: Paclitaxel for Injection（Albumin Bound）; Drug: carboplatin; Radiation: thoracic radiation therapy

Interventions

Paclitaxel for Injection（Albumin Bound） DRUG

concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks

Also known as: Abraxane®

chemoradiotherapy

carboplatin DRUG

concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks

chemoradiotherapy

thoracic radiation therapy RADIATION

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

chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (2)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310002, China

RECRUITING

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

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

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Shenglin Ma, MD

  The First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xia, MD, PhD

CONTACT

86 18857110928; bxia_hzch@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the hospital

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 19, 2011
• Study Start: July 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

CN (2)