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

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel for Injection（Albumin Bound）

carboplatin

thoracic radiation therapy

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Squamous Cell Lung Cancer, radiation therapy, chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hangzhou Cancer HospitalRecruiting
The First People's Hospital of Hangzhou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemoradiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

tumor response rate

Secondary Outcome Measures

progression-free survival

overall survival

esophagitis

acute esophagitis of Grade III and above

Full Information

NCT ID

NCT01494415

First Posted

December 14, 2011

Last Updated

December 13, 2015

Sponsor

First People's Hospital of Hangzhou

1. Study Identification

Unique Protocol Identification Number

NCT01494415

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First People's Hospital of Hangzhou

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Squamous Cell Lung Cancer, radiation therapy, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chemoradiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel for Injection（Albumin Bound）

Other Intervention Name(s)

Abraxane®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

thoracic radiation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

tumor response rate

Time Frame

one month after the end of all treatment

Secondary Outcome Measure Information:

Title

progression-free survival

Time Frame

2 years from patient enrollment

Title

overall survival

Time Frame

2 years from patient enrollment

Title

esophagitis

Description

acute esophagitis of Grade III and above

Time Frame

6 mouths from the initiation of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Xia, MD, PhD

Phone

86 18857110928

bxia_hzch@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shenglin Ma, MD

Organizational Affiliation

The First People's Hospital of Hangzhou

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hangzhou Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bing Xia, MD

Phone

0571-56006035

bxia_hzch@hotmail.com

First Name & Middle Initial & Last Name & Degree

Bing Xia, MD

Facility Name

The First People's Hospital of Hangzhou

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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