分疗程胸部放疗联合白蛋白结合型紫杉醇加奈达铂治疗基线肺功能受损的局部晚期 NSCLC
研究概览
详细说明
这项 II 期随机研究旨在确定分程胸部放疗联合白蛋白结合型紫杉醇加奈达铂治疗基线肺功能严重受损的局部晚期非小细胞肺癌的疗效。
患者每周接受四个周期的白蛋白结合型紫杉醇(50mg/㎡)和奈达铂(25mg/㎡),每次持续1天,或每周两次白蛋白结合型紫杉醇(30mg/㎡)和奈达铂(10mg/㎡),同时分疗程胸部放疗,分别在第一疗程和第二疗程中进行 30 Gy/6 次和 40 Gy/8 次放疗,休息一个月。 主要终点是无进展生存期,即从放疗第一天到疾病进展之日的时间。 将使用 Kaplan-Meier 方法计算无进展生存期。毒性将根据 CTCAE v. 4.0 分级。
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Guangzhou、中国、510060
- Sun Yat-sen University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- NSCLC的病理证实。
- 根据实体瘤反应评估标准 (RECIST) 标准,患者具有可测量或可评估的病变。
- 中重度阻塞性通气功能障碍(FEV1.0/FVC≤60%), 或/和中重度限制性通气功能障碍(FEV1.0/FVC≤60%,TLC-SB(Act1/Pred)≤80%), 或/和中重度弥散功能障碍(DLCOc/VA(Act1/Pred)≤60%)。
- 经 EBUS 证实的不可切除的 IIIA(N2) 期和 IIIB 期肺癌。
- 全肺V20>=35%时给予60Gy,这是根治性照射的最小剂量。
- 东部肿瘤合作组 (ECOG) 表现状态 0-1。
- 以前接受过化疗或未接受过治疗
- 以前没有胸部放射治疗、免疫治疗或生物治疗
- 血红蛋白≥10 mg/dL,血小板≥100000/μL,中性粒细胞绝对计数≥1500/μL
- 血清肌酐≤1.25倍正常上限(UNL),或肌酐清除率≥60ml/min
- 胆红素≤1.5倍UNL,AST(SGOT)≤2.5倍UNL,ALT(SGPT)≤2.5倍UNL,碱性磷酸酶≤5倍UNL
- CB6 在正常范围内
- 患者及家属签署知情同意书
排除标准:
- 先前或最近的另一种恶性肿瘤,非黑色素瘤皮肤癌或原位宫颈癌除外
- 化疗禁忌症
- 恶性胸膜或心包积液。
- 怀孕、哺乳期或首次给药前 14 天未进行妊娠试验的女性
- 不采取避孕措施有可能怀孕的妇女
- 出血倾向
- 在 30 天内进行其他临床试验
- 吸毒或酗酒、爱滋病患者
- 无法控制的癫痫发作或没有自控能力的精神病患者
- 严重过敏或异质
- 研究人员判断不适合本研究
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:分程放射治疗
放射治疗采用同步综合增强放射治疗 (SIB) 调强放射治疗 (IMRT) 进行。 将 30Gy 的剂量和 5Gy 的分次剂量递送至 PTV-GTV 作为 low-RT 疗程。 当没有疾病进展并且没有持续≥G2治疗相关的毒性时,患者有资格接受低加强治疗。 对于持续≥G2毒性的患者,计划每两周进行一次重新评估,以确定他们是否有资格接受低加强治疗。 所有符合条件的患者均接受重复 4DCT 模拟扫描,以重新制定适应性放射治疗计划。 低加强的适应性计划以 30Gy 的剂量分 6 次(每次 5 Gy)递送至残余肿瘤(PTV-GTV-残余)。 患者每周接受多西紫杉醇 (25 mg/m2) 和顺铂 (25 mg/m2) 输注,同时进行低放疗和低加强治疗。 整个治疗过程中预期化疗包括 4 个周期。 |
放射治疗采用同步综合增强放射治疗 (SIB) 调强放射治疗 (IMRT) 进行。
将 30Gy 的剂量和 5Gy 的分次剂量递送至 PTV-GTV 作为 low-RT 疗程。
当没有疾病进展并且没有持续≥G2治疗相关的毒性时,患者有资格接受低加强治疗。
对于持续≥G2毒性的患者,计划每两周进行一次重新评估,以确定他们是否有资格接受低加强治疗。
所有符合条件的患者均接受重复 4DCT 模拟扫描,以重新制定适应性放射治疗计划。
低加强的适应性计划以 30Gy 的剂量分 6 次(每次 5 Gy)递送至残余肿瘤(PTV-GTV-残余)。
患者每周接受多西紫杉醇 (25 mg/m2) 和顺铂 (25 mg/m2) 输注,同时进行低放疗和低加强治疗。
整个治疗过程中预期化疗包括 4 个周期。
胸部放疗后无疾病进展或持续2+级毒性的患者建议接受巩固免疫治疗
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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无进展生存期
大体时间:2年
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2年
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次要结果测量
结果测量 |
大体时间 |
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总生存期
大体时间:2年
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2年
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3-4级放射性食管炎的发生率
大体时间:1年
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1年
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3-4级放射性肺炎发生率
大体时间:1年
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1年
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反应速度
大体时间:2个月
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2个月
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合作者和调查者
调查人员
- 首席研究员:Hui Liu, Ph.D、Sun Yat-sen University
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
分程放射治疗的临床试验
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All India Institute of Medical Sciences, New Delhi完全的
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Avita MedicalUnited States Department of Defense; Royal Perth Hospital; MedDRA Assistance Inc; BioStat International...完全的
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University Hospital, GhentJules Bordet Institute; AZ Sint-Lucas Gent; GZA Ziekenhuizen Campus Sint-Augustinus; AZ Sint-Lucas...完全的