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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Pre-operative chemotherapy
* Other: Pre-operative concurrent chemoradiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-operative chemotherapy<br>Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles) | Drug: Pre-operative chemotherapy<br>* Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)<br>|
| Active Comparator: Pre-operative concurrent chemoradiation therapy<br> | Other: Pre-operative concurrent chemoradiation therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the time to recurrence |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pathologic complete response rate and the complete resection rate |  | Every 4 weeks | 
| To estimate toxicities |  | Every 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy