Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
详细描述
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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:
- •Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
- •Squamous cell carcinoma
- •Basaloid carcinoma
- •Adenocarcinoma
- •Bronchoalveolar carcinoma
- •Adenosquamous carcinoma
- •Large cell carcinoma
- •Large cell neuroendocrine carcinoma
- •Giant cell carcinoma
- •Sarcomatoid carcinoma
- •Non-small cell carcinoma not otherwise specified
- •Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
- •No metastatic disease or hilar or mediastinal lymphadenopathy
- •Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
- •No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
- •Poor surgical risk, as defined by 1 of the following:
- •High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
- •Pulmonary dysfunction indicated by one or more of the following:
- •FEV_1 less than 40% of predicted
- •DLCO less than 50% of predicted
- •Oxygen dependent
- •Chronic PaCO_2 greater than 45 mm Hg
- •VO_2 less than 15 mL/kg/min
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No weight loss of more than 10% within the past 6 months
- •No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
- •Chemotherapy:
- •No prior chemotherapy for NSCLC
- •Radiotherapy:
- •No prior chest radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
干预措施: accelerated conformational radiotherapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: Up to 5 years
Failure-free survival
时间窗: Up to 5 years
次要结局
未报告次要终点