A Phase Ⅰ/Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy in Patients With Locally Advanced Esophageal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.
详细描述
Despite the application of IMRT and the studies of concurrent chemoradiation in esophageal carcinoma, which improves 5-year survival rate from 10% to 20%-40% and decrease recurrence rate from 80% to 50%-60%, local recurrence remains to be the most common failure pattern. Therefore, enhancing local control is the key to obtain a better survival.
A phase Ⅱ study of radical radiotherapy with IMRT simultaneous integrated boost technique and concurrent chemotherapy for esophageal carcinoma use the same radiation dose as the high dose arm in RTOG 94-05, which reveals an significantly improved median survival time of 23 months and 3-year overall survival rate of 44.4%. This study implies the simultaneous integrated boost technique may be effective to some extent. But the question is how to identify patients who may gain potential benefits, and whether this therapeutic model can be copied in the specific situation in China? Few adverse effects such as perforation, hemorrhage and stenosis was reported, mainly owing to the lack of cases. For widely application of this new technique in the clinic, more studies need to be conducted in the future to obtain sufficient evidence.
The current IMRT can simultaneously achieve prophylactic dose (DT 50Gy) and radical dose (DT 60-64Gy) in respective target volume by using inverse intensity-modulated planning system. However, it is still controversial on whether esophageal carcinoma can receive prescription dose more than 2.0Gy each time. That is to say, it is challengeable to find an optimal fraction dose and total dose between tumor and adverse effects. For this reason, the dose escalation trial is to be conducted to explore the clinical value and optimal dose to esophageal carcinoma with different radiosensitivity, and also provide data support for phase Ⅲ clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of clinical stage T2-4N0-1M1a untreated squamous esophageal carcinoma
- •Adequate organ function
- •No known history of drug allergy
排除标准
- •Known drug allergy
- •Insufficient hepatorenal function
- •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
Radical 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: IMRT simultaneous integrated boost (Radiation)
Radical 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
Radical 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: Nedaplatin (Drug)
Radical 2.17
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.17Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: IMRT simultaneous integrated boost (Radiation)
Radical 2.17
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.17Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
Radical 2.17
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.17Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: Nedaplatin (Drug)
Radical 2.21
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.21Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: IMRT simultaneous integrated boost (Radiation)
Radical 2.21
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.21Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
Radical 2.21
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.21Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.
干预措施: Nedaplatin (Drug)
Neoadjuvant 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 4 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.
干预措施: IMRT simultaneous integrated boost (Radiation)
Neoadjuvant 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 4 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.
干预措施: Paclitaxel (Drug)
Neoadjuvant 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 4 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.
干预措施: Nedaplatin (Drug)
Neoadjuvant 2.14
Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively.
Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 4 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.
干预措施: Esophagectomy (Procedure)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: up to 3 years
次要结局
- Overall survival (OS)(up to 5 years)
研究者
Zefen Xiao
Professor
Chinese Academy of Medical Sciences