A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Acute Toxicity and Quality of LIfe
研究概览
简要总结
The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.
详细描述
This is a phase II study using tomotherapy for radiation treatment delivery along with concurrent 5-FU/mitomycin C for the treatment of T2-T4 cancer of the anal canal. They hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head. This is expected to limit or reduce treatment related toxicity and hence prevent or reduce treatment breaks. This may result in delivery of radical treatment with better local control and treatment outcome than using the current radiation treatment technique at our center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient should have histologically proven primary squamous carcinoma or its variant
- •No history of prior malignancy.
- •Patients must be free of metastatic disease out of pelvis at the time of diagnosis
- •Patients must be at least 18 years of age
- •Performance status 0, 1 or 2 ECOG
- •T stage 2-4, Any N, stage MO
- •Patient should be eligible for concomitant chemotherapy
- •Informed written consent required to participate
排除标准
- •Prior radiation to pelvis
- •Pregnant or lactating
- •prior surgical treatment for anal cancer other than biopsy
- •prior surgical or chemotherapy treatment for anal cancer
- •T1 tumours (2cm) or evidence of distant mets
- •comorbid medical conditions precluding radical treatment at the discretion of oncologist
结局指标
主要结局
Acute Toxicity and Quality of LIfe
时间窗: 3 months
次要结局
- colostomy-free survival and/or overall survival(3 and 5 years)
- Local Recurrence(3 and 5 years)