Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- radiation pneumonitis and radiation esophagitis
研究概览
简要总结
This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.
详细描述
Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable design the clinical target volume of lymph node drainage area has always been controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved lymph node area according to different sites, in order to contrast advantages and disadvantages of the two kind of target area design，so the study was designed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80
- •ECOG performance status 0-2
- •Weight is not less than 90% of it before treatment
- •Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III
- •Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective)
- •WBC ≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
- •Platelets ≥ 100X109/L
- •Hemoglobin ≥ 90g/L(without blood transfusion)
- •AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
- •Creatinine ≤ 1.5 x upper limit of normal
- •Sign study-specific informed consent prior to study entry -
排除标准
- •Multiple primary esophageal tumors
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- •Severe, active comorbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- •Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
研究组 & 干预措施
Involved Field Irradiation(IFI)
Involved Field Irradiation(IFI):The clinical target volume of regional lymph node (CTVn) of IFI included the nodal region(s) in which the involved lymph node(s) was/were located.chemothrapy:docetaxel and cisplatin.
干预措施: Involved Field Irradiation(IFI) (Radiation)
Involved Field Irradiation(IFI)
Involved Field Irradiation(IFI):The clinical target volume of regional lymph node (CTVn) of IFI included the nodal region(s) in which the involved lymph node(s) was/were located.chemothrapy:docetaxel and cisplatin.
干预措施: docetaxel and cisplatin (Drug)
Elective Nodal Irradiation (ENI)
Elective Nodal Irradiation (ENI):The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17 were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.chemothrapy:docetaxel and cisplatin.
干预措施: docetaxel and cisplatin (Drug)
Elective Nodal Irradiation (ENI)
Elective Nodal Irradiation (ENI):The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17 were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.chemothrapy:docetaxel and cisplatin.
干预措施: Elective Nodal Irradiation (ENI) (Radiation)
结局指标
主要结局
radiation pneumonitis and radiation esophagitis
时间窗: Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years
radiation pneumonitis and radiation esophagitis,
次要结局
- 3-year Overall survival(OS)(CT scans performed every 6 months for 3 years)
- 3-year Disease-free survival(CT scans every 6 months for 3 years)
- Quality of life(QoL)(Evaluation of quality of life every week for 3 months)
- Local control rate/ Inside irrational field recurrence rate(2 year)
研究者
Chengya Chou
Chairman of Radiotherapy department
The Second People's Hospital of Sichuan