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

Guangzhou Medical University

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Other: Pre-operative concurrent chemoradiation therapy; Drug: Pre-operative chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01054482

FAHG20070218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Pre-operative chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Pre-operative chemotherapy

Pre-operative concurrent chemoradiation therapy

Active Comparator group

Treatment:

Other: Pre-operative concurrent chemoradiation therapy