A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Pre-operative chemotherapy
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To estimate the time to recurrence
- Last Updated
- 16 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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: Pre-operative chemotherapy
Pre-operative concurrent chemoradiation therapy
Intervention: Pre-operative concurrent chemoradiation therapy
Outcomes
Primary Outcomes
To estimate the time to recurrence
Time Frame: Every 3 months
Secondary Outcomes
- To assess the pathologic complete response rate and the complete resection rate(Every 4 weeks)
- To estimate toxicities(Every 4 weeks)