NCT00776100终止2 期
A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated With Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 168
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after chemotherapy, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation after chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess whether the addition of radiotherapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival of patients with oligometastatic stage IV non-small cell lung cancer.
Secondary
- To compare the progression-free survival of patients treated with radiotherapy vs observation after standard chemotherapy.
- To compare the time to disease progression and time to treatment failure in these patients.
- To compare the confirmed response rate in these patients.
- To compare the duration of response in these patients.
- To compare the adverse events in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- •Mixed histology allowed if all components are consistent with NSCLC
- •Squamous cell histology allowed
- •Stage IV disease
- •Oligometastatic disease (M1 with 1-3 metastases)
- •Patients with M1 disease that involves intrapulmonary metastases are eligible provided ≤ 40% of the total lung volume receives ≥ 20 Gy of radiotherapy
- •Previously untreated disease OR achieved stable disease or partial response within 8 weeks after completion of 2-6 courses of standard platinum-based chemotherapy (administered every 3-4 weeks)
- •Pleural effusion allowed provided it is minimal
- •No history of or current brain metastases
- •Patients who have had up to 3 brain metastases allowed provided they have been treated with not signs of progression
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy ≥ 12 weeks
- •Platelet count ≥ 100,00/mm^3
- •Hemoglobin ≥ 9 g/dL
- •WBC ≥ 2,000/mm^3
- •Creatinine ≤ 2 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to undergo radiotherapy, based on radiation oncology consultation
- •Willing and able to comply with study treatment
- •FEV_1 ≥ 1 L
- •No requirement for daily supplemental oxygen
- •No second primary malignancy, except for any of the following:
- •Carcinoma in situ of the cervix
- •Nonmelanoma skin cancer
- •History of low-grade (Gleason score ≤ 6) localized prostate cancer, even if diagnosed within the past 5 years
- •Stage I breast cancer that was treated within the past 5 years
- •Other malignancy that was diagnosed and definitely treated ≥ 5 years ago with no subsequent evidence of recurrence
- •No concurrent severe and/or uncontrolled medical condition, including any of the following:
- •Angina pectoris
- •Congestive heart failure within the past 3 months, unless LVEF > 40%
- •Myocardial infarction within the past 6 months
- •Cardiac arrhythmia
- •No clinically significant infection
- •No psychiatric illness or social situation that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior therapy for this cancer other than 2-6 courses of standard platinum-based chemotherapy with or without bevacizumab
- •No prior radiotherapy to the treatment sites (e.g., primary lesion, clinically involved nodes, or metastatic lesions)
- •No bevacizumab during and for 4 weeks after completion of radiotherapy
- •No concurrent systemic chemotherapy
- •No other maintenance systemic therapy during radiotherapy
- •No other concurrent investigational agents for the primary neoplasm
- •No concurrent intensity modulated radiotherapy
- •No concurrent prophylactic nodal radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Other
Patients undergo observation for 6 weeks.
干预措施: clinical observation (Other)
Arm II
Experimental
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall Survival
时间窗: Time from registration to death or last follow-up (up to 5 years)
Overall survival was defined as the time from registration to the date of death or last follow-up
次要结局
- Response Rate(Up to 5 years)
- Progression-free Survival(Time from registration to disease progression or death (up to 5 years))
- Time to Disease Progression(Time from registration to disease progression (up to 5 years))
- Time to Treatment Failure(Up to 5 years)
- Duration of Response(Up to 5 years)
研究者
研究点 (168)
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