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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Pre-operative chemotherapy; Other: Pre-operative concurrent chemoradiation therapy

• Registration Number: NCT01054482
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Status Verified: 2007-01
• Study Start: 2007-02
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02
• Primary Completion: 2011-01
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-operative chemotherapy	Pre-operative chemotherapy	Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op \& Post-Op (total 4 cycles)
Pre-operative concurrent chemoradiation therapy	Pre-operative concurrent chemoradiation therapy	-

Primary Outcome Measures

Name	Time	Method
To estimate the time to recurrence	Every 3 months

Secondary Outcome Measures

Name	Time	Method
To assess the pathologic complete response rate and the complete resection rate	Every 4 weeks
To estimate toxicities	Every 4 weeks

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China