A Randomized Phase II Trial Evaluating The Addition Of Nimotuzumab To Chemoradiation For Patients With Esophageal Squamous Cell Carcinoma After Radical Esophagectomy Who Suffer With Lymph Nodes Recurrence
试验速览
- 阶段
- 2 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Local control
研究概览
简要总结
A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to chemoradiation for patients with esophageal squamous cell carcinoma after radical esophagectomy who suffer with locoregional lymph nodes recurrence.
详细描述
Patient population:
Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy.
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by recurrent time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after esophagectomy), then randomized to 2 arms at 1:1 ratio.
Arm A:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤75
- •ECOG performance status 0-2
- •Histologically proven primary thoracic esophageal squamous cell carcinoma before
- •Diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
- •Period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
- •Without prior radiotherapy
- •Weight loss no more than 10% in the past 6 months
- •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
- •With recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum)
- •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:
- •3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 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 radiation therapy or prior target drug therapy
研究组 & 干预措施
A
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
干预措施: Nimotuzumab (Biological)
A
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
干预措施: radiation therapy (Radiation)
A
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
干预措施: chemotherapy (Drug)
B
Patients randomized in Arm B will receive chemoradiation only
干预措施: radiation therapy (Radiation)
B
Patients randomized in Arm B will receive chemoradiation only
干预措施: chemotherapy (Drug)
结局指标
主要结局
Local control
To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
次要结局
- Adverse Events
- Overall survival