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



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

For Condition: stage 3A non-small cell lung cancer,stage 2 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Washington Hospital Center ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidPerry,  Study Chair,  Washington Cancer Institute

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Shakun  Malik 202-444-2242

Washington Cancer Institute *Recruiting*
Washington D.C.,  District of Columbia,  20010
United States
Recruiting David  Perry 202-877-2843

Franklin Square Hospital Center *Recruiting*
Baltimore,  Maryland,  21237
United States
Recruiting Sein  Aung 443-777-7534


Additional Information:
Study ID Numbers:
  CDR0000068288;  WHC-99444,NCI-V00-1632
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006469

Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

2. Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer

3. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

4. Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

5. Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

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

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