Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
This trial is active, not recruiting.
|Treatments||carboplatin, paclitaxel, radiation therapy|
|Sponsor||Baptist Health South Florida|
|Start date||March 2000|
|Trial identifier||NCT00004253, BHM-99-64, BHM-L1, CDR0000067500, NCI-V99-1582|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Patients with unresected locally advanced non-small cell lung cancer - Stage II, IIIA, or IIIB - No evidence of hematogenous metastases - No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) - No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 2,000/mm3 - Platelet count at least 130,000/mm3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No active or symptomatic cardiac disease - No acute myocardial infarction within the past 6 months - No angina - No congestive heart failure - No uncontrolled arrhythmias - Cardiac ejection fraction greater than 50% Pulmonary: - FEV1 at least 1.25 L AND - DLCO at least 50% predicted Other: - Not pregnant - Fertile patients must use effective contraception - Weight loss no greater than 5% within 3 months of diagnosis - No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior thoracic or neck radiotherapy Surgery: - See Disease Characteristics
|Official title||A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin|
|Description||OBJECTIVES: - Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT). - Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients. - Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines. - Determine the feasibility of patient-specific dose escalation using this regimen in these patients. - Determine the quality of life and symptom distress in these patients on this regimen. OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT). Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks. Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels. Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months. Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.|
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