NCT00004253Unknown2 期
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
Baptist Health South Florida4 个研究点 分布在 1 个国家开始时间: 2000年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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)
- •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%
- •FEV1 at least 1.25 L AND
- •DLCO at least 50% predicted
- •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
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (4)
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