Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Treatments||carboplatin, paclitaxel, conventional surgery, neoadjuvant therapy, radiation therapy|
|Sponsor||Washington Hospital Center|
|Start date||August 1999|
|Trial size||30 participants|
|Trial identifier||NCT00006469, CDR0000068288, NCI-V00-1632, WHC-99444|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Washington, DC||Washington Cancer Institute at Washington Hospital Center||no longer recruiting|
|Baltimore, MD||Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center||no longer recruiting|
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
Disease-free and overall survival at 3 and 5 years after completion of study treatment
Male or female participants at least 18 years old.
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
|Official title||Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) Non-Small Cell Lung Cancer|
|Description||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.|
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