Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer

Medstar Health Research Institute30 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these treatments before surgery may kill more tumor cells in patients with non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer.

OBJECTIVES: * Determine the response rate, duration of response, and survival in patients with bulky stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection. * Assess the toxicity of this regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5 weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the absence of unacceptable toxicity. At approximately 4 weeks after completion of chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If disease is unresectable, patients receive an additional 2 weeks of radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer * Ipsilateral mediastinal node involvement by mediastinoscopy * No contralateral lymph node involvement * No malignant pleural effusion * No distant metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * ALT/AST less than 2 times upper limit of normal * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics

Outcomes

Primary Outcomes

Pathologic response rate

as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment.

Time frame: 3-5 Years

Disease-free and overall survival at 3 and 5 years after completion of study treatment