A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For both step I and II:
- •Patients with histologically confirmed squamous cell carcinoma of the anal canal
- •Aged 18 years or older
- •ECOG: 0-1-2
- •Adequate contraception in women of child-bearing potential and for men
- •Ability to understand and the willingness to sign a written informed consent document.
- •HIV-positive patients with T1-2 anal canal tumors, or
- •Patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
- •Patients who have already started radiotherapy for anal canal cancer
- •For step II:
- •HIV-positive patients with T1, T2 anal canal tumors
- •HIV-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
- •HIV-negative patients with T1-2 anal canal cancer
排除标准
- •For both step I and II:
- •Patients receiving any other investigational agents
- •Previous treatment with anti-EGFR drugs
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study.
- •Previously treated with pelvic radiotherapy.
- •Lesions not suitable for radiotherapy
- •Patients with uncontrolled hypercalcemia
- •Uncontrolled intercurrent illness
- •Pregnant or breast-feeding women
- •Any concurrent active malignancy
- •Patients with T3-4 anal canal tumors or patients with nodes positive.
- •HIV-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-FU and MMC chemotherapy
研究组 & 干预措施
Nimotuzumab
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
干预措施: Nimotuzumab (Drug)
Nimotuzumab
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
干预措施: Intensity Modulated Radiation Therapy (IMRT) (Radiation)
结局指标
主要结局
Toxicity
时间窗: 1 month post end of treatment
Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
Local tumor response rate
时间窗: 8 weeks post end of radiation treatment
Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.
次要结局
- Overall cancer-free survival(5 years post end of treatment)
- Overall survival(5 years post end of treatment)
研究者
Dr. Te Vuong
MD-Director Radiation Oncology
Sir Mortimer B. Davis - Jewish General Hospital