NCT00083083Unknown2 期
Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 49
- 主要终点
- Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
研究概览
简要总结
RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.
PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.
Secondary
- Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
- Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
- Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
- Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 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 confirmed non-small cell lung cancer (NSCLC)
- •Clinical stage IIB or III disease
- •No small cell carcinoma
- •No stage IV disease*
- •No diffuse bronchoalveolar subtype
- •No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation
- •Planning treatment with definitive chemoradiotherapy
- •May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
- •Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
- •No brain metastases by head CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
- •Able to tolerate positron emission tomography imaging
- •No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL)
- •No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy
- •Chemotherapy
- •See Disease Characteristics
- •No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior thoracic radiotherapy
- •No concurrent intensity-modulated radiotherapy
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
次要结局
- Relationship of survival to post-treatment max SUV as determined by the imaging institute
- Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
- Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
- Reliability between peak and max SUV measurements both pre- and post-treatment
- Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
- Reliability between PET scan-defined response to therapy measurements
- Correlation of Ki-67 expression with peak and max pre-treatment SUV
- Association between Ki-67 expression and overall survival at 2 years
研究者
研究点 (49)
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