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

• To assess the pathologic complete response rate and the complete resection rate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
• To estimate toxicities [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

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.

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.

• Drug: 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)
• Other: Pre-operative concurrent chemoradiation therapy

  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

• Experimental: 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)
  Intervention: Drug: Pre-operative chemotherapy
• Active Comparator: Pre-operative concurrent chemoradiation therapy
  Intervention: Other: Pre-operative concurrent chemoradiation therapy

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.