Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 115
- 主要终点
- Overall Survival (12-month Rate Reported)
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy.
Secondary
- To compare treatment-related adverse events in these patients.
- To evaluate patterns of failure in these patients.
- To compare the time to first failure in these patients.
- To evaluate the percentage of the planned radiotherapy dose given to each site.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months*
- •Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment with chemotherapy
- •Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria:
- •Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if radiotherapy has been delivered to primary disease with chemotherapy, there must be complete or partial response in ≥ 1 of the sites that has not been treated with radiotherapy)
- •No progression in any site
- •No limited stage SCLC, even if disease progressed
- •No brain or central nervous system (CNS) metastases
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-2
- •Absolute neutrophil count (ANC) ≥ 1,000/mm^3
- •Platelets ≥ 75,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)
- •Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)
- •Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the liver)
- •Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the kidneys)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No severe, active co-morbidity, defined as any of the following:
- •Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study registration
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy and alopecia])
- •Thoracic radiotherapy administered concurrently with or before chemotherapy for the current diagnosis allowed (these patients will not receive mediastinal radiotherapy per protocol)
- •No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- •No concurrent chemotherapy
排除标准
- 未提供
研究组 & 干预措施
PCI
Prophylactic Cranial Irradiation (PCI)
干预措施: Prophylactic Cranial Irradiation (Radiation)
PCI + Consolidation RT
Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
干预措施: Prophylactic Cranial Irradiation (Radiation)
PCI + Consolidation RT
Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Overall Survival (12-month Rate Reported)
时间窗: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months. The 12-month rate is reported.
次要结局
- Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event(From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.)
- Patterns of Failure - Number of Patients With Failure by Site(From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.)
- First Failure (12-month Rate Reported)(From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.)
- Percentage of Planned Radiotherapy Dose (All Sites) That Was Delivered(From start to end of radiation therapy; up to 32 days for Prophylactic Cranial Irradiation arm, up to 68 days for Prophylactic Cranial Irradiation + Consolidation Radiotherapy arm.)