KCT0006837尚未招募未知
MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)
ational Cancer Center0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1 Disease Related Criteria
- •- Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
- •- Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal
- •disease. Patient also must not have a history of brain metastases or leptomeningeal disease.
- •2 Prior/Concurrent Therapy Criteria
- •- Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with LS-SCLC must
- •have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do
- •not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the
- •treating physician but is not required. Patients with ES-SCLC must have completed the platinum-based chemotherapy component of their treatment
- •- All adverse events from prior treatment must have resolved to = Grade 2 (CTCAE Version 5.0) prior to randomization.
- •- Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (CT or PET/CT including the chest and abdomen) must be performed within 42 days prior to randomization.
- •- No more than 16 weeks may have elapsed between Day 1 of the last cycle of chemotherapy and randomization.
- •- Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery
- •for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Please
- •contact Dr. Chad Rusthoven at chad.rusthoven@cuanschutz.edu for inquiries.
- •3 Clinical/Laboratory Criteria
- •-Patient must be = 18 years of age. (Korea = 19)
- •-Patient must have Zubrod Performance Status of 0-2 (see Section 10.9).
- •-Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies.
- •- Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
- •- Patient must not have other metastatic malignancies requiring current active treatment.
- •- Patient must not have any severe active comorbidities, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to randomization
- •Transmural myocardial infarction within 3 months prior to randomization
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
- •Acute severe exacerbation of chronic obstructive pulmonary disease or other acute respiratory illness precluding study therapy at the time of
- •randomization
- •Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
- •HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly
- •active antiretroviral therapy (HAART) and have a CD4 count = 200 cells/microliter within 16 weeks prior to randomization. Note also that HIV testing
- •is not required for eligibility for this protocol.
- •- Patient must not be pregnant because of fetal risks from radiation
排除标准
- •Included in inclusion criteria
研究者
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