Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
研究概览
地位
条件
详细说明
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.
Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.
Data of 218 cases of our hospital indicated patients received radiation dose > 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had <54Gy. The optimal radiation dose should be further investigated.
The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.
The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Lei Deng, MD
- 电话号码：+86-18611766429
- 邮箱：dengleipumc@163.com
学习地点
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Beijing
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Beijing、Beijing、中国、100021
- 招聘中
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
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接触：
- Zefen Xiao, MD
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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
有资格学习的性别
描述
Inclusion Criteria:
- Locoregional recurrence after radical surgery;
- Positive resection margin (R1/R2) after surgery;
- Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;
- Recurrence after adjuvant chemotherapy;
- No prior therapy after recurrence;
- Age 16-70 years;
- KPS>70;
- No history of drug allergy;
- Sufficient liver and kidney functions;
- White blood cell count > 4.0*10^9/L.
Exclusion Criteria:
- Age>70 or <16 years;
- Pregnancy or lactation;
- History of drug allergy;
- Declining informed consent;
- Insufficient liver or kidney functions, or abnormal CBC test;
- Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Involved field irradiation
Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f.
Chest CT scan is planned at 50Gy.
Radiation field should be modified according to the tumor response.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
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Involved field irradiation; intensity-modulated radiation therapy
Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
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实验性的：Elective field irradiation
Patients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f.
For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a sequential boost of 10-12Gy/1.8-2Gy/5-7f.
For patients whose planned thoracic stomach V50>50%, the dose should be lowered to 45Gy/1.8Gy/25f.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF should be given in need.
If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
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Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Elective field irradiation; intensity-modulated radiation therapy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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1、2、3 年总生存期
大体时间：从治疗开始到因任何原因或审查员死亡，评估长达 36 个月
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总生存期
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从治疗开始到因任何原因或审查员死亡，评估长达 36 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1、2、3 年无进展生存期
大体时间：从治疗开始到第一次记录到进展或死亡或审查，评估长达 36 个月
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无进展生存期
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从治疗开始到第一次记录到进展或死亡或审查，评估长达 36 个月
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1-, 2-, 3-year local progression-free survival
大体时间：From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
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Local progression-free survival
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From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
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Simultaneously integrated boost radiation therapy completion rate
大体时间：During chemoradation, assessed up to 60 days
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Radiation therapy completion rate
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During chemoradation, assessed up to 60 days
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Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
大体时间：Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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Toxicities of chemoradiation therapy
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Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
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Involved field irradiation的临床试验
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Boston Scientific Corporation招聘中