Lung Cancer Clinical Trial
Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
Summary
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.
Full 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.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Washington District of Columbia, 20010, United States
Baltimore Maryland, 21237, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.