A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02
试验速览
- 阶段
- 3 期
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Overall survival（OS）
研究概览
简要总结
This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
- •A untreated squamous esophageal carcinoma
- •Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
- •Adequate organ function
- •No known history of drug allergy
- •Blood routine examination : WBC≥4.0
- •hepatic and renal function are normal
排除标准
- •Age≥ 70 or < 18
- •Already received the treatment of chemotherapy or radiotherapy
- •Pregnant or lactating females
- •Known drug allergy
- •Without agreement of informed consent form
- •Insufficient hepatorenal function or Blood routine examination
- •Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
研究组 & 干预措施
SIB-IMRT combined chemotherapy followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
干预措施: SIB-IMRT (Radiation)
SIB-IMRT combined chemotherapy followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
干预措施: Paclitaxel (Drug)
SIB-IMRT combined chemotherapy followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
干预措施: Platinum-Based Drug (Drug)
SIB-IMRT Alone followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
干预措施: SIB-IMRT (Radiation)
SIB-IMRT Alone followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
干预措施: Paclitaxel (Drug)
SIB-IMRT Alone followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
干预措施: Platinum-Based Drug (Drug)
结局指标
主要结局
Overall survival（OS）
时间窗: 3 year
次要结局
- Progress free survival（PFS）(3 year)
- Local recurrence-free rate（LRFS）(3 year)
- Completion Rate(up to 2 year)
- Adverse events(up to 5 year)
研究者
Zefen Xiao
Principal Investigator
Chinese Academy of Medical Sciences