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Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pre-operative chemotherapy

Pre-operative concurrent chemoradiation therapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histopathologic diagnosis of non small-cell lung cancer
Clinical stage IIIA and/or IIIB without pleural effusion
ECOG functional status 0 or 1
No renal function alteration (GFR >50%)
No hepatic function alteration (ALT and AST less than 2 times its normal value)
Leucocytes more than 2,000/mcl
Hemoglobin more than 10mg/dL
Platelets more than 100,000/mcl

Exclusion Criteria:

Active uncontrolled infection.
Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
Significant neurological or mental disorder.
Second primary malignancy.
Pregnant or nursing.

Sites / Locations

The First Affiliated Hospital of Guangzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-operative chemotherapy

Pre-operative concurrent chemoradiation therapy

Arm Description

Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)

Outcomes

Primary Outcome Measures

To estimate the time to recurrence

Secondary Outcome Measures

To assess the pathologic complete response rate and the complete resection rate

To estimate toxicities

Full Information

NCT ID

NCT01054482

First Posted

January 21, 2010

Last Updated

February 1, 2010

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01054482

Brief Title

Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

Official Title

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

February 2007 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.

Detailed Description

Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.

6. Conditions and Keywords

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

Non-small Cell Lung Cancer

Keywords

Neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pre-operative chemotherapy

Arm Type

Experimental

Arm Description

Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)

Arm Title

Pre-operative concurrent chemoradiation therapy

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Pre-operative chemotherapy

Intervention Description

Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)

Intervention Type

Other

Intervention Name(s)

Pre-operative concurrent chemoradiation therapy

Intervention Description

Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op & Post-Op: 2 cycles (total 4 cycles). Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Primary Outcome Measure Information:

Title

To estimate the time to recurrence

Time Frame

Every 3 months

Secondary Outcome Measure Information:

Title

To assess the pathologic complete response rate and the complete resection rate

Time Frame

Every 4 weeks

Title

To estimate toxicities

Time Frame

Every 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histopathologic diagnosis of non small-cell lung cancer Clinical stage IIIA and/or IIIB without pleural effusion ECOG functional status 0 or 1 No renal function alteration (GFR >50%) No hepatic function alteration (ALT and AST less than 2 times its normal value) Leucocytes more than 2,000/mcl Hemoglobin more than 10mg/dL Platelets more than 100,000/mcl Exclusion Criteria: Active uncontrolled infection. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia. Significant neurological or mental disorder. Second primary malignancy. Pregnant or nursing.

Central Contact Person:

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

Jianxing He, MD, FACS

Phone

+86-20-83337792

drjianxing.he@gmail.com

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

Daoyuan Wang, MD

Phone

+86-20-83337792

ghealth2008@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianxing He, MD, FACS

Organizational Affiliation

The First Affiliated Hospital of Guangzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Guangzhou Medical College

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenlong Shao, MD

Phone

+86-20-83337750

Ext

7040

myfriends2003@126.com

First Name & Middle Initial & Last Name & Degree

Daoyuan Wang, MD

Phone

+86-20-83337750

Ext

7040

ghealth2008@gmail.com

First Name & Middle Initial & Last Name & Degree

Jianxing He, MD, FACS

12. IPD Sharing Statement

Learn more about this trial

Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

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